(221 days)
The Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device, Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The colors of the proposed device are Blue, Black, and Indigo.
The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Examination Gloves. This type of medical device is a Class I device and does not fall under the category of AI/ML-powered medical devices that would typically involve the comprehensive testing and data requirements outlined in the prompt's request.
Therefore, the document does not contain the information requested regarding acceptance criteria and study proving device meets acceptance criteria for an AI/ML-powered device. Specifically:
- No AI/ML Component: The device is a physical examination glove, not an AI/ML system.
- No Comparative Effectiveness Study: There is no multi-reader multi-case (MRMC) comparative effectiveness study, as it's not a diagnostic or AI-assisted interpretation device.
- No Standalone Algorithm Performance: The concept of standalone algorithm performance does not apply to a physical glove.
- No Ground Truth Establishment for AI Models: The document describes physical and biological testing for a glove (e.g., tensile strength, pinholes, biocompatibility), not the establishment of ground truth for training or testing an AI model.
- No Training or Test Sets for AI: The terms "training set" and "test set" in the context of AI/ML are not applicable to the non-clinical testing performed for these gloves.
- No Expert Adjudication for AI: The biological and physical tests performed for gloves do not involve expert radiologists or other medical experts establishing ground truth for AI performance.
The document focuses on demonstrating substantial equivalence to a predicate device (K150340) through non-clinical performance testing for physical properties and biocompatibility.
However, to answer the prompt based on the information that is present in the document for this specific device (Powder Free Nitrile Examination Gloves), I will present the acceptance criteria for the physical and biological properties of the gloves and their performance results.
Acceptance Criteria and Device Performance (for Powder Free Nitrile Examination Gloves)
The study proves the device meets the acceptance criteria through non-clinical performance testing, demonstrating substantial equivalence to a legally marketed predicate device (K150340).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ASTM standards (D6319, D6124-06, D5151 06) and ISO 10993 series for biological evaluation. The results consistently "Meet requirement" or show compliance with the specified criteria.
| Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties (from Tables 2/8/14) | |||
| Tensile Strength (Unaged) | To assess the glove's strength before aging. | ≥ 14 MPa | ≥ 14 MPa (Meets requirement of ASTM D6319) |
| Elongation at Break (Unaged) | To assess the glove's elasticity before aging. | ≥ 500% | ≥ 500% (Meets requirement of ASTM D6319) |
| Tensile Strength (Aged) | To assess the glove's strength after accelerated aging. | ≥ 14 MPa | ≥ 14 MPa (Meets requirement of ASTM D6319) |
| Elongation at Break (Aged) | To assess the glove's elasticity after accelerated aging. | ≥ 400% | ≥ 400% (Meets requirement of ASTM D6319) |
| Freedom of Holes (ASTM D5151 06) | To detect holes in medical gloves. | Samples: 500 gloves; AQL: 2.5 (ISO 2859); Criterion: ≤ 21 gloves for water leakage | Requirement met. |
| Residual Powder (ASTM D6124-06) | To determine the amount of residual powder on medical gloves. | Powder residue limit of 2.0 mg/glove | Avg. S: 0.30 mg/glove, M: 0.31 mg/glove, L: 0.45 mg/glove (Requirement met). |
| Biocompatibility (from Tables 6/12/18) | |||
| ISO 10993-10:2010 (Skin Sensitization) | Assesses possible contact hazards from chemicals, specifically skin sensitization. | Grades Less than 1.0 (<1.0) or no sensitization. Scoring: Less than 1.0 (<1.0), no erythema/oedema. | No evidence of causing skin contact sensitization. |
| ISO 10993-10:2010 (Irritation) | Assesses possible contact hazards from chemicals, specifically skin and mucosal irritation. | Scoring: Less than 1.0 (<1.0), no erythema/oedema. | No erythema/edema; considered non-irritant. |
| ISO 10993-5:2009 (In Vitro Cytotoxicity) | Assesses in vitro cytotoxicity of medical devices. | Number of viable L929 mouse fibroblasts counts in direct method should be more than 70% to pass the test. | Cells beneath test samples did not show signs of cytotoxicity; glove is non-cytotoxic to L-292 cell lines. |
| ISO 10993-10:2010 (Intracutaneous Reactivity) | Evaluated for intracutaneous reactivity potential on single topical application. | Requirement met if difference between test extract mean score and control mean score was 1.0 or less. | No erythema and no edema; considered a non-irritant. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Physical Testing (Freedom of Holes): 500 gloves.
- Sample Size for Residual Powder: Data presented for S, M, L sizes, implying multiple gloves tested per size, but the exact number isn't specified beyond "average powder residue for each size".
- Sample Size for Biocompatibility Tests: Not explicitly stated numerically (e.g., number of animals for skin sensitization/intracutaneous reactivity, number of cell cultures for cytotoxicity), but the results indicate that the studies were performed "Under the conditions of this study," implying established biological testing protocols were followed.
- Data Provenance: The tests are non-clinical (laboratory-based physical and biological assays), not patient data. The document does not specify the country of origin for the testing itself, but the manufacturer is based in Malaysia (AMMEX Malaysia SDN BHD). These are prospective tests performed as part of the submission process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable as the device is a physical examination glove undergoing standardized physical and biocompatibility testing, not an AI/ML-powered diagnostic or interpretive device. The "ground truth" for these tests is established by the test methodology and the measuring equipment/protocols, not by expert human graders or clinicians.
4. Adjudication Method for the Test Set
This is not applicable as the device is a physical examination glove. Standardized laboratory testing methods directly produce results against defined acceptance criteria. There is no human interpretation or adjudication step in the sense of consensus among multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study is not applicable for a physical medical glove. MRMC studies are typically performed for diagnostic imaging devices or AI-assisted interpretation tools to evaluate reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This is not applicable as the device is a physical medical glove, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of these gloves is based on:
- Established ASTM Standards: For physical properties like tensile strength, elongation, freedom of holes, and residual powder.
- Established ISO 10993 Standards for Biological Evaluation: For biocompatibility tests like skin sensitization, irritation, cytotoxicity, and intracutaneous reactivity.
These standards define the acceptable range or qualitative outcome (e.g., non-irritant, non-cytotoxic) that constitutes "meeting the requirement."
8. The Sample Size for the Training Set
Not applicable. This term relates to machine learning models, which are not part of this device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI/ML product, there is no training set or ground truth establishment in this context.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 18, 2021
Ammex Corporation Davendran Tangaya Manager of Compliance & Product Development 1019 W James St. Suite 200 Kent, Washington 98032
Re: K211457
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 20, 2021 Received: November 26, 2021
Dear Davendran Tangaya:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K211457
Device Name
Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
Indications for Use (Describe)
The Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, green letters, with a blue line underneath. To the right of the word is a blue gear symbol.
510(k) Summary
The assigned 510(k) Number: K211457
- Date of Preparation: 16 Dec 2021
-
- Sponsor
Ammex Corporation 1019 W James St #200, Kent, WA 98032, United States Contact Person: Sasitharan Nair Position: Senior VP of Global Sourcing and Product Innovation Tel: + 425-251-4000 Fax: + 425-251-4621 Email: snair(@ammex.com
- Sponsor
- Submission Correspondent
Ammex Corporation
1019 W James St #200, Kent, WA 98032, United States Contact Person: Davendran Position: Manager of Compliance & Product Development Tel: + 425-251-4000 Fax: + 425-251-4621 Email: dtangaya@ammex.com
- Proposed Device Identification
Trade Name: Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) Common Name: Nitrile Patient Examination Gloves (Powder Free)
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image contains the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters. Below the word is the text "Malaysia SDN BHD" in a smaller font. To the right of the word is a blue gear symbol.
Regulatory Information: Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Product Name: Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
Indication for Use Statement:
The Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.
-
Predicate Device Identification 510(k) Number: K150340 Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Product Name: Powder Free Nitrile Gloves (White, Cobalt Blue, Black, Ice Blue) Manufacturer: HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD
-
Device Description
The proposed device, Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image contains the logo for AMMEX Malaysia SDN BHD. The word "AMMEX" is written in large, bold, green letters. Below the word is the text "Malaysia SDN BHD" in smaller, blue letters. To the right of the word is a blue gear.
The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The colors of the proposed device are Blue, Black, and Indigo. Product Reference Number: APFN4X100 (Blue) Product Reference Number: ABNPF4X100 (Black) Product Reference Number: AINPF4X100 (Indigo)
- Technological Characteristics Comparison with predicate device (Blue)
A. Powder Free Nitrile Examination Gloves - Blue
| Size | Length (mm) | Width (mm) | Thickness (mm) | |||
|---|---|---|---|---|---|---|
| Extra Small | $\u2265 230$ | 75 \u00b1 5 mm | Finger0.10\u00b10.02 | Palm0.08\u00b10.02 | Cuff0.06\u00b10.02 | |
| Small | 85 \u00b1 5 mm | |||||
| Medium | 95 \u00b1 5 mm | |||||
| Large | 105 \u00b1 5 mm | |||||
| Extra Large | 115 \u00b1 5 mm | |||||
| Color | Blue |
Table 1: Device Size Specifications
Table 2: Performance and Physical Specifications (For XS, S, M, L, XL)
| Property | Unit | Conditioning | Specification | Pinhole AQL |
|---|---|---|---|---|
| Tensile Strength | MPa | Unaged | $\ge 14$ | $\le 2.5$ |
| Elongation at Break | % | $\ge 500$ | ||
| Tensile Strength | MPa | Aged | $\ge 14$ | |
| Elongation at Break | % | $\ge 400$ |
Discussion: The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319
| Characteristics andParameters | Proposed Device:Powder Free NitrileExamination Gloves(Blue) | Predicate Device:Powder Free NitrileExamination Gloves(White, Cobalt Blue,Black, Ice Blue) | Comparison |
|---|---|---|---|
| 510(k) number | K211457 | K150340 | Different |
| Product Code | LZA | LZA | Same |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in bold, green letters, with the "X" stylized in a lighter green. Below the word "AMMEX" is the text "Malaysia SDN BHD" in a smaller font. To the right of the text is a blue gear graphic.
| Intended Use | The Powder Free Nitrile Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. | The Powder Free Nitrile Gloves (White, Cobalt Blue, Black, Ice Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | Same |
|---|---|---|---|
| Classification | Class 1 | Class 1 | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Raw Rubber Material | Nitrile (Acrylonitrile-butadiene) | Nitrile (Acrylonitrile-butadiene) | Same |
| Surface Treatment / Powder or Powder Free | Powder Free | Powder Free | Same |
| Surface Appearance | 1. Ambidextrous2. Finger Textured | 1. Ambidextrous2. Finger Textured | Same |
| Color | Blue | White, Cobalt Blue, Black & Ice Blue | DifferentColors |
Table 4: Device Dimension Comparison Table
| Proposed Device:Powder Free NitrileExamination Gloves(Blue)(K211457) | Designation | XS | S | M | L | XL | Tolerance |
|---|---|---|---|---|---|---|---|
| Length, mm | 230 | 230 | 230 | 230 | 230 | Minimum | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | $\pm$ 10 | |
| Thickness, mm | |||||||
| Finger | 0.10-0.12 | $\pm$ 0.02 | |||||
| Palm | 0.08-0.10 | $\pm$ 0.02 | |||||
| Cuff | 0.06-0.07 | $\pm$ 0.02 | |||||
| Predicate Device:Powder Free NitrileExamination Gloves(White, Cobalt Blue,Black, Ice Blue)(K150340) | Designation | XS | S | M | L | XL | Tolerance |
| Length, mm | 230 | 230 | 230 | 230 | 230 | Minimum | |
| Width, mm | 70 | 80 | 95 | 110 | 120 | $\pm$ 10 | |
| Thickness, mm | |||||||
| Finger | 0.10-0.12 | $\pm$ 0.03 | |||||
| Palm | 0.08-0.10 | $\pm$ 0.03 | |||||
| Cuff | 0.06-0.09 | $\pm$ 0.03 |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters. Below the word "AMMEX" is the text "Malaysia SDN BHD" in a smaller font. To the right of the word "AMMEX" is a blue gear.
Discussion: The sizes and tolerances of proposed device are different with those of the predicate.
| Characteristics andParameters | Proposed Device:Powder Free NitrileExamination Gloves(Blue)(K211457) | Predicate Device:Powder Free NitrileExaminationGloves (White,Cobalt Blue, Black,Ice Blue) (K150340) | Comparison |
|---|---|---|---|
| Tensile Strength(before age)Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement ofTensile Strength underASTM D6319 |
| Tensile Strength (afterage) Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement ofTensile Strength underASTM D6319 |
| Ultimate Elongation(before age) Minimum14 MPa | Min 500% | Min 500% | Meeting requirement ofelongation under ASTMD6319 |
| Ultimate Elongation(after age) Minimum 14MPa | Min 400% | Min 400% | Meeting requirement ofelongation under ASTMD6319 |
| Freedom of Holes MeetAQL 2.5 at G1 | Meet AQL 1.5 withG1 | Meet AQL 1.5 withG1 | Meeting requirement offreedom of holes underASTM D6319 |
| Residual powder test(Less than 2mg / glove) | Average powderresidue for each size:S: 0.30 mg/gloveM: 0.31 mg/gloveL: 0.45 mg/glove | Contained less than2 mg/glove | Meeting requirement ofpowder residue underASTM D6319 |
| Primary Skin Irritation(Surface-contacting, lessthan 24 hoursduration) | Under the conditionsof study, not an irritant | Under the conditionsof study, not anirritant | Yes, both are tested to benon-irritant |
| Dermal Sensitization(Surface-contacting, lessthan 24 hoursduration) | Under the conditionsof study, not asensitizer | Under the conditionsof study, not asensitizer | Yes, both are tested to benon-sensitizer |
| In Vitro Cytotoxicity(Surface-contacting, lessthan 24 hours duration) | Under the conditionsof study, non-cytotoxic | Not tested | The predicate device wasnot tested for In VitroCytotoxicity |
| Intracutaneous Reactivity | Under the conditionsof study, not an irritant | Not tested | The predicate device wasnot tested forIntracutaneous reactivity |
Table 5: Device Performance Comparison
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image contains the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters, with a blue line underneath. To the right of the word is a blue gear symbol. Below the word "AMMEX" is the text "Malaysia SDN BHD".
Discussion: The proposed device has different color to the predicate device.
-
- Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
- Summary of Non-Clinical Performance Testing
| Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10:2010Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and SkinSensitization. | This part of ISO 10993 assesses possiblecontact hazards fromchemicals releasedfrom medical devices,which may produceskin and mucosalirritation, eye irritationor skin sensitization. | Skin Sensitization Test:Provided gradesLess than 1.0 (<1.0),otherwise sensitization.0- No visible change1- Discrete erythema2- Moderate erythema3- Intense erythemaScoring: Less than 1.0 (<1.0), no erythema /oedema. Since thescoring is less than 1, the response category isnegligible.0- No erythema /oedema1- Slight erythema /oedema2- Well defined erythema /oedema | Under the conditions of thisstudy, the gloves showed noevidence of causing skincontact sensitization.Under the condition of thisstudy, there was no erythema/edema. The gloves areconsidered non-irritant. |
| 3- Moderate erythema/oedema4- Severe erythema/oedema | |||
| ISO 10993-5:2009Biological EvaluationOfMedical Devices -Part5: Tests For In VitroCytotoxicity | This part of ISO10993 describes testmethods to assess thein vitro cytotoxicity ofmedical devices. | For biocompatible, ifthe number of viableL929 mouse fibroblastscounts in direct methodshould be more than70% to pass the test. | The study finds that the cellsbeneath the test samplesincubated for 72 hours did notshow any signs ofcytotoxicity. The glove isnon-cytotoxic to L-292 celllines. |
| ISO 10993-10: 2010Biological Evaluationof Medical Devices-Test for Irritation andSkin Sensitization-part10: Tests forIntracutaneousReactivity | The test articleidentified below wasevaluated forintracutaneousreactivity potential onsingle topicalapplication. | The requirements of thetest were met if thedifference between thetest extract mean scoreand control mean scorewas 1.0 or less.0-No erythema/oedema1-Slight erythema/oedema2-Well definederythema /oedema3-Moderate erythema/oedema4- Severe erythema/oedema | Under the conditions of thisstudy, there was no erythemaand no edema. The glove isconsidered a non- irritant. |
| ASTM D6124-06(Reapproved 2017),Standard Test Methodfor Residual Powderon Medical Gloves | This standard isdesigned to determinethe amount of residualpowder (or filter-retained mass) foundon medical gloves. | Powder residue limit of2.0 mg | Requirement met. |
| ASTM D5151 06(Reapproved 2015),Standard Test Methodfor Detection of Holesin Medical Gloves. | This test methodcovers the detectionof holes in medicalgloves. | Samples number: 500glovesAQL: 2.5 (ISO 2859)Criterion ≤ 21 glovesfor water leakage | Requirement met. |
Table 6: Summary of Non-Clinical Performance Testing
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image is a logo for AMMEX Malaysia SDN BHD. The word "AMMEX" is written in large, bold, green letters. Below the word "AMMEX" is the phrase "Malaysia SDN BHD" in smaller, blue letters. To the right of the word "AMMEX" is a blue gear.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image is a logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters. Below the word "AMMEX" is the text "Malaysia SDN BHD" in smaller, blue letters. To the right of the word "AMMEX" is a blue gear.
-
- Summary of Clinical Performance Test
No clinical study is included in this submission.
- Summary of Clinical Performance Test
-
- Photograph of Powder Free Nitrile Examination Gloves (Blue)
Product Reference Number: APFN4X100
- Photograph of Powder Free Nitrile Examination Gloves (Blue)
('X' on the Product Reference Number denotes the size of the glove, please refer Attachment 15)
Image /page/10/Picture/7 description: The image shows a blue, disposable glove. The glove is laid flat on a white surface. The glove is wrinkled and has five fingers.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters, with the "X" stylized to incorporate a blue gear shape. Below the word "AMMEX" is the text "Malaysia SDN BHD" in a smaller font. The image also contains the text "11. Conclusion".
The conclusions drawn from the nonclinical tests demonstrate that the proposed device, (K211457: Powder Free Nitrile Examination Gloves, in Blue is as safe, as effective, and performs as well as or better than the legally marketed predicated device, (K150340: Powder Free Nitrile Examination Gloves in White, Cobalt Blue, Black, and Ice Blue.
12. Summary comparing technological characteristics with predicate device (Black)
B. Powder Free Nitrile Examination Gloves – Black
| Size | Length (mm) | Width (mm) | Thickness (mm) | |||
|---|---|---|---|---|---|---|
| Extra Small | ≥ 230 | 75 ± 5 mm | Finger0.10±0.02 | Palm0.08±0.02 | Cuff0.06±0.02 | |
| Small | 85 ± 5 mm | |||||
| Medium | 95 ± 5 mm | |||||
| Large | 105 ± 5 mm | |||||
| Extra Large | 115 ± 5 mm | |||||
| Color | Black |
Table 7: Device Size Specifications
Table 8: Performance and Physical Specifications (For XS, S, M, L, XL)
| Property | Unit | Conditioning | Specification | Pinhole AQL |
|---|---|---|---|---|
| Tensile Strength | MPa | Unaged | $\ge 14$ | $\le 2.5$ |
| Elongation at Break | % | $\ge 500$ | ||
| Tensile Strength | MPa | Aged | $\ge 14$ | |
| Elongation at Break | % | $\ge 400$ |
Discussion: The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319
- Technological Characteristic Comparison
| Characteristics andParameters | Proposed Device: PowderFree Nitrile ExaminationGloves (Black) | Predicate Device: PowderFree Nitrile ExaminationGloves (White, CobaltBlue, Black, Ice Blue) | Comparison |
|---|---|---|---|
| 510(k) number | K211457 | K150340 | Different |
| Product Code | LZA | LZA | Same |
Table 9: Device General Comparison Table
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in bold, green letters, with a blue line underneath. Below the line, the words "Malaysia SDN BHD" are written in a smaller font. To the right of the word "AMMEX" is a blue gear symbol.
| Intended Use | The Powder Free NitrileExamination Gloves is adisposable device intendedfor medical purpose that isworn on the examiner'shands to preventcontamination betweenpatient and examiner. | The Powder Free NitrileGloves (White, Cobalt Blue,Black, Ice Blue) is adisposable device intendedfor medicalpurposes that is worn on theexaminer's hands to preventcontamination betweenpatient and examiner. | Same |
|---|---|---|---|
| Classification | Class 1 | Class 1 | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Raw Rubber Material | Nitrile (Acrylonitrile-butadiene) | Nitrile (Acrylonitrile-butadiene) | Same |
| Surface Treatment /Powder or Powder Free | Powder Free | Powder Free | Same |
| Surface Appearance | 3. Ambidextrous4. Finger Textured | 3. Ambidextrous4. Finger Textured | Same |
| Color | Black | White, Cobalt Blue, Black &Ice Blue | Different Colors |
Table 10: Device Dimension Comparison Table
| Proposed Device:Powder Free NitrileExamination Gloves(Black)(K211457) | Designation | XS | S | M | L | XL | Tolerance | Characteristics andParameters | Proposed Device:Powder Free NitrileExamination Gloves(Black)(K211457) | Predicate Device:Powder Free NitrileExaminationGloves (White,Cobalt Blue, Black,Ice Blue) (K150340) | Comparison |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Length, mm | 230 | 230 | 230 | 230 | 230 | Minimum | Tensile Strength(before age)Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement ofTensile Strength underASTM D6319 | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | ± 10 | Tensile Strength (afterage) Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement ofTensile Strength underASTM D6319 | |
| Thickness, mm | Ultimate Elongation(before age) Minimum14 MPa | Min 500% | Min 500% | Meeting requirement ofelongation under ASTMD6319 | |||||||
| Finger | 0.10-0.12 | ±0.02 | Ultimate Elongation(after age) Minimum 14MPa | Min 400% | Min 400% | Meeting requirement ofelongation under ASTMD6319 | |||||
| Palm | 0.08-0.10 | ±0.02 | Freedom of Holes MeetAQL 2.5 at G1 | Meet AQL 1.5 withG1 | Meet AQL 1.5 withG1 | Meeting requirement offreedom of holes underASTM D6319 | |||||
| Cuff | 0.06-0.07 | ±0.02 | Residual powder test(Less than 2mg / glove) | Average powderresidue for each size:S: 0.30 mg/gloveM: 0.31 mg/gloveL: 0.45 mg/glove | Contained less than2 mg/glove | Meeting requirement ofpowder residue underASTM D6319 | |||||
| Predicate Device:Powder Free NitrileExamination Gloves(White, Cobalt Blue,Black, Ice Blue)(K150340) | Designation | XS | S | M | L | XL | Tolerance | Primary Skin Irritation(Surface-contacting, lessthan 24 hoursduration) | Under the conditionsof study, not an irritant | Under the conditionsof study, not anirritant | Yes, both are tested to benon-irritant |
| Length, mm | 230 | 230 | 230 | 230 | 230 | Minimum | Dermal Sensitization(Surface-contacting, lessthan 24 hoursduration) | Under the conditionsof study, not asensitizer | Under the conditionsof study, not asensitizer | Yes, both are tested to benon-sensitizer | |
| Width, mm | 70 | 80 | 95 | 110 | 120 | ± 10 | In Vitro Cytotoxicity(Surface-contacting, lessthan 24 hoursduration) | Under the conditionsof study, non-cytotoxic | Not tested | The predicate device wasnot tested for In VitroCytotoxicity | |
| Thickness, mm | |||||||||||
| Finger | 0.10-0.12 | ±0.03 | |||||||||
| Palm | 0.08-0.10 | ±0.03 | |||||||||
| Cuff | 0.06.0.09 | ±0.03 |
Discussion: The sizes and tolerances of proposed device are different with those of the predicate.
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters. Below the word "AMMEX" is the text "Malaysia SDN BHD" in a smaller font. To the right of the word "AMMEX" is a blue gear.
Table 11: Device Performance Comparison
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, green letters. Below the word is the text "Malaysia SDN BHD" in a smaller font. To the right of the word is a blue gear.
| Intracutaneous Reactivity | Under the conditionsof study, not an irritant | Not tested | The predicate device wasnot tested forIntracutaneous reactivity |
|---|---|---|---|
| --------------------------- | --------------------------------------------------- | ------------ | ------------------------------------------------------------------------- |
Discussion: The proposed device has different color to the predicate device.
- Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
| Name of the TestMethodology /Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10:2010Biological Evaluationof Medical Devices -Part 10: Tests forIrritation and SkinSensitization. | This part of ISO 10993assesses possiblecontact hazards fromchemicals releasedfrom medical devices,which may produceskin and mucosalirritation, eye irritationor skin sensitization. | Skin Sensitization Test:Provided gradesLessthan 1.0 (<1.0),otherwise sensitization.0- No visible change1- Discrete erythema2- Moderate erythema3- Intense erythema | Under the conditions of thisstudy, the gloves showed noevidence of causing skincontact sensitization. |
| Scoring: Less than 1.0(<1.0), no erythema/oedema. Since thescoring is less than 1,the response category isnegligible.0- No erythema/oedema1- Slight erythema/oedema2- Well definederythema /oedema3- Moderate erythema/oedema4- Severe erythema/oedema | Under the condition of thisstudy, there was no erythema/edema. The gloves areconsidered non-irritant. | ||
| ISO 10993-5:2009Biological EvaluationOfMedical Devices -Part5: Tests For In VitroCytotoxicity | This part of ISO10993 describes testmethods to assess thein vitro cytotoxicity ofmedical devices. | For biocompatible, ifthe number of viableL929 mouse fibroblastscounts in direct methodshould be more than70% to pass the test. | The study finds that the cellsbeneath the test samplesincubated for 72 hours did notshow any signs ofcytotoxicity. The glove isnon-cytotoxic to L-292 celllines. |
| ISO 10993-10: 2010Biological Evaluationof Medical Devices-Test for Irritation andSkin Sensitization-part 10: Tests forIntracutaneousReactivity | The test articleidentified below wasevaluated forintracutaneousreactivity potential onsingle topicalapplication. | The requirements of thetest were met if thedifference between thetest extract mean scoreand control mean scorewas 1.0 or less.0-No erythema/oedema1-Slight erythema/oedema2-Well definederythema /oedema3-Moderate erythema/oedema4- Severe erythema/oedema | Under the conditions of thisstudy, there was no erythemaand no edema. The glove isconsidered a non- irritant. |
| ASTM D6124-06(Reapproved 2017),Standard Test Methodfor Residual Powderon Medical Gloves | This standard isdesigned to determinethe amount of residualpowder (or filter-retained mass) foundon medical gloves. | Powder residue limit of2.0 mg | Requirement met. |
| ASTM D5151 06(Reapproved 2015),Standard Test Methodfor Detection of Holesin Medical Gloves. | This test methodcovers the detectionof holes in medicalgloves. | Samples number: 500glovesAQL: 2.5 (ISO 2859)Criterion < 21 glovesfor water leakage | Requirement met. |
Table 12: Summary of Non-Clinical Performance Testing
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in bold, green letters, with the "X" stylized to resemble a gear. Below the word "AMMEX" is the text "Malaysia SDN BHD" in a smaller font. The gear is blue.
15. Summary of Clinical Performance Test
No clinical study is included in this submission.
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The word "AMMEX" is written in large, bold, green letters. Below the word is a blue line, and below the line is the text "Malaysia SDN BHD" in a smaller font. To the right of the word "AMMEX" is a blue gear.
16. Photograph of Powder Free Nitrile Examination Gloves (Black)
Product Reference Number: ABNPF4X100
('X' on the Product Reference Number denotes the size of the glove, please refer Attachment 15)
Image /page/16/Picture/4 description: The image shows a hand wearing a black glove. The glove appears to be made of a smooth, possibly latex or nitrile material. The hand is positioned with the palm facing forward and the fingers extended. The background is a plain white surface.
17. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device, (K211457: Powder Free Nitrile Examination Gloves, in Black is as safe, as effective, and performs as well as or better than the legally marketed predicated device, (K150340: Powder Free Nitrile Examination Gloves in White, Cobalt Blue, Black, and Ice Blue.
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters. Below the word "AMMEX" is the text "Malaysia SDN BHD" in smaller, blue letters. To the right of the word "AMMEX" is a blue gear.
18. Summary comparing technological characteristics with predicate device (Indigo)
C. Powder Free Nitrile Examination Gloves - Indigo
Table 13: Device Size Specifications
| Size | Length (mm) | Width (mm) | Thickness (mm) | ||
|---|---|---|---|---|---|
| Extra Small | ≥ 230 | 75 ± 5 mm | Finger0.10±0.02 | Palm0.08±0.02 | Cuff0.06±0.02 |
| Small | 85 ± 5 mm | ||||
| Medium | 95 ± 5 mm | ||||
| Large | 105 ± 5 mm | ||||
| Extra Large | 115 ± 5 mm | ||||
| Color | Indigo |
Table 14: Performance and Physical Specifications (For XS, S, M, L, XL)
| Property | Unit | Conditioning | Specification | Pinhole AQL |
|---|---|---|---|---|
| Tensile Strength | MPa | Unaged | $\ge$ 14 | $\le$ 2.5 |
| Elongation at Break | % | $\ge$ 500 | ||
| Tensile Strength | MPa | Aged | $\ge$ 14 | |
| Elongation at Break | % | $\ge$ 400 |
Discussion: The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319.
19. Technological Characteristics Comparison
Table 15: Device General Comparison Table
| Characteristics andParameters | Proposed Device: PowderFree Nitrile ExaminationGloves (Indigo)(K211457) | Predicate Device: PowderFree Nitrile ExaminationGloves (White, CobaltBlue, Black, Ice Blue)(K150340) | Comparison |
|---|---|---|---|
| 510(k) number | K211457 | K150340 | Different |
| Product Code | LZA | LZA | Same |
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The word "AMMEX" is written in large, green, bold letters. Underneath the word "AMMEX" is the phrase "Malaysia SDN BHD" written in smaller, dark blue letters. To the right of the text is a blue gear.
| Intended Use | The Powder Free NitrileExamination Gloves is adisposable device intendedfor medical purpose that isworn on the examiner'shands to preventcontamination betweenpatient and examiner. | The Powder Free NitrileGloves (White, CobaltBlue, Black, Ice Blue) is adisposable device intendedfor medicalpurposes that are worn onthe examiner's hands toprevent contaminationbetween patient andexaminer. | Same |
|---|---|---|---|
| Classification | Class 1 | Class 1 | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Raw Rubber Material | Nitrile (Acrylonitrile-butadiene) | Nitrile (Acrylonitrile-butadiene) | Same |
| Surface Treatment /Powder or Powder Free | Powder Free | Powder Free | Same |
| Surface Appearance | 0- Ambidextrous1- Finger Textured | 5. Ambidextrous6. Finger Textured | Same |
| Color | Indigo | White, Cobalt Blue, Black &Ice Blue | Different Colors |
Table 16: Device Dimension Comparison Table
| Proposed Device:Powder Free NitrileExamination Gloves(Indigo)(K211457) | Designation | XS | S | M | L | XL | Tolerance |
|---|---|---|---|---|---|---|---|
| Length, mm | 230 | 230 | 230 | 230 | 230 | Minimum | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | ± 10 | |
| Thickness, mm | |||||||
| Finger | 0.10-0.12 | ±0.02 | |||||
| Palm | 0.08-0.10 | ±0.02 | |||||
| Cuff | 0.06-0.07 | ±0.02 | |||||
| Predicate Device:Powder Free NitrileExamination Gloves(White, Cobalt Blue,Black, Ice Blue)(K150340) | Designation | XS | S | M | L | XL | Tolerance |
| Length, mm | 230 | 230 | 230 | 230 | 230 | Minimum | |
| Width, mm | 70 | 80 | 95 | 110 | 120 | ± 10 | |
| Thickness, mm | |||||||
| Finger | 0.10-0.12 | ±0.03 | |||||
| Palm | 0.08-0.10 | ±0.03 | |||||
| Cuff | 0.06.0.09 | ±0.03 |
Discussion: The sizes and tolerances of proposed device are different with those of the predicate.
{19}------------------------------------------------
Image /page/19/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The word "AMMEX" is written in large, bold, green letters. Below the word is a blue line, and below the line is the text "Malaysia SDN BHD" in a smaller font. To the right of the word "AMMEX" is a blue gear.
Table 17: Device Performance Comparison
| Characteristics andParameters | Proposed Device:Powder Free NitrileExamination Gloves(Indigo)(K211457) | Predicate Device:Powder Free NitrileExaminationGloves (White,Cobalt Blue, Black,Ice Blue) (K150340) | Comparison |
|---|---|---|---|
| Tensile Strength(before age)Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement ofTensile Strength underASTM D6319 |
| Tensile Strength (afterage) Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement ofTensile Strength underASTM D6319 |
| Ultimate Elongation(before age) Minimum14 MPa | Min 500% | Min 500% | Meeting requirement ofelongation under ASTMD6319 |
| Ultimate Elongation(after age) Minimum 14MPa | Min 400% | Min 400% | Meeting requirement ofelongation under ASTMD6319 |
| Freedom of Holes MeetAQL 2.5 at G1 | Meet AQL 1.5 withG1 | Meet AQL 1.5 withG1 | Meeting requirement offreedom of holes underASTM D6319 |
| Residual powder test(Less than 2mg / glove) | Average powderresidue for each size:S: 0.30 mg/gloveM: 0.31 mg/gloveL: 0.45 mg/glove | Contained less than2 mg/glove | Meeting requirement ofpowder residue underASTM D6319 |
| Primary Skin Irritation(Surface-contacting, lessthan 24 hoursduration) | Under the conditionsof study, not an irritant | Under the conditionsof study, not anirritant | Yes, both are tested to benon-irritant |
| Dermal Sensitization(Surface-contacting, lessthan 24 hoursduration) | Under the conditionsof study, not asensitizer | Under the conditionsof study, not asensitizer | Yes, both are tested to benon-sensitizer |
| In Vitro Cytotoxicity(Surface-contacting, lessthan 24 hoursduration) | Under the conditionsof study, non-cytotoxic | Not tested | The predicate device wasnot tested for In VitroCytotoxicity |
| Intracutaneous Reactivity | Under the conditionsof study, not an irritant | Not tested | The predicate device wasnot tested forIntracutaneous reactivity |
{20}------------------------------------------------
Image /page/20/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, green letters. Below the word is the text "Malaysia SDN BHD" in smaller, blue letters. To the right of the word is a blue gear.
Discussion: The proposed device has different color to the predicate device.
- Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
| Name of the TestMethodology /Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10:2010Biological Evaluationof Medical Devices -Part 10: Tests forIrritation and SkinSensitization. | This part of ISO 10993assesses possiblecontact hazards fromchemicals releasedfrom medical devices,which may produceskin and mucosalirritation, eye irritationor skin sensitization. | Skin Sensitization Test:Provided gradesLessthan 1.0 (<1.0),otherwise sensitization.1- No visible change2- Discrete erythema3- Moderate erythema4- Intense erythemaScoring: Less than 1.0(<1.0), no erythema/oedema. Since thescoring is less than 1,the response category isnegligible.0- No erythema/oedema1- Slight erythema/oedema | Under the conditions of thisstudy, the gloves showed noevidence of causing skincontact sensitization.Under the condition of thisstudy, there was no erythema/edema. The gloves areconsidered non-irritant. |
| 2- Well definederythema /oedema3- Moderate erythema/oedema4- Severe erythema/oedema | |||
| ISO 10993-5:2009Biological EvaluationOfMedical Devices -Part5: Tests For In VitroCytotoxicity | This part of ISO10993 describes testmethods to assess thein vitro cytotoxicity ofmedical devices. | For biocompatible, ifthe number of viableL929 mouse fibroblastscounts in direct methodshould be more than70% to pass the test. | The study finds that the cellsbeneath the test samplesincubated for 72 hours did notshow any signs ofcytotoxicity. The glove isnon-cytotoxic to L-292 celllines. |
| ISO 10993-10: 2010Biological Evaluationof Medical Devices-Test for Irritation andSkin Sensitization—part10: Tests for systemictoxicity | The test articleidentified below wasevaluated forintracutaneousreactivity potential onsingle topicalapplication. | The requirements of thetest were met if thedifference between thetest extract mean scoreand control mean scorewas 1.0 or less.0-No erythema/oedema1-Slight erythema/oedema2-Well definederythema /oedema3-Moderate erythema/oedema4-Severe erythema/oedema | Under the conditions of thisstudy, there was no erythemaand no edema. The glove isconsidered a non- irritant. |
| ASTM D6124-06(Reapproved 2017),Standard Test Methodfor Residual Powderon Medical Gloves | This standard isdesigned to determinethe amount of residualpowder (or filter-retained mass) foundon medical gloves | Powder residue limit of2.0 mg | Requirement met. |
| ASTM D5151 06(Reapproved 2015),Standard Test Methodfor Detection of Holesin Medical Gloves. | This test methodcovers the detectionof holes in medicalgloves. | Samples number: 500glovesAQL: 2.5 (ISO 2859)Criterion ≤ 21 glovesfor water leakage | Requirement met. |
Table 18: Summary of Non-Clinical Performance Testing
{21}------------------------------------------------
Image /page/21/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The word "AMMEX" is written in large, bold, green letters. Below the word "AMMEX" is the phrase "Malaysia SDN BHD" in smaller, blue letters. To the right of the word "AMMEX" is a blue gear.
{22}------------------------------------------------
Image /page/22/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The word "AMMEX" is written in large, green, bold letters. Below the word "AMMEX" is the phrase "Malaysia SDN BHD" in smaller, blue letters. To the right of the word "AMMEX" is a blue gear.
- Summary of Clinical Performance Test
No clinical study is included in this submission.
- Photograph of Powder Free Nitrile Examination Gloves (Indigo)
Product Reference Number: AINPF4X100
('X' on the Product Reference Number denotes the size of the glove, please refer Attachment 15)
Image /page/22/Picture/7 description: The image shows a blue nitrile glove. The glove is laid flat on a white surface. The glove is wrinkled and has a slightly shiny surface.
23. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device, (K211457: Powder Free Nitrile Examination Gloves, in Indigo is as safe, as effective, and performs as well as or better than the legally marketed predicated device, (K150340: Powder Free Nitrile Examination Gloves in White, Cobalt Blue, Black, and Ice Blue.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.