(221 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No.
The device (nitrile examination gloves) is intended to prevent contamination, not to treat or cure a disease or condition.
No
The device, Powder Free Nitrile Examination Gloves, is described as a disposable device worn on the examiner's hands to prevent contamination between patient and examiner. Its function is to provide a barrier and prevent contamination, not to detect, diagnose, or monitor a disease or condition.
No
The device is a physical product (gloves) and the summary describes performance testing related to material properties and physical integrity, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description reinforces the barrier function and mentions variations in size and color, which are not relevant to in vitro diagnostics.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical properties of the gloves (tensile strength, elongation, freedom from holes, residual powder) and biocompatibility (skin sensitization, irritation, cytotoxicity). These are relevant to a barrier device, not an IVD.
- Key Metrics: The key metrics are related to the physical integrity and quality of the gloves, not diagnostic accuracy (sensitivity, specificity, etc., although these terms are listed, they are not applied to a diagnostic context here).
In summary, the device is a medical glove intended for barrier protection, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
Purpose: This part of ISO 10993 assesses possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization.
Results: Under the conditions of this study, the gloves showed no evidence of causing skin contact sensitization. Under the condition of this study, there was no erythema/edema. The gloves are considered non-irritant.
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
Purpose: This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices.
Results: The study finds that the cells beneath the test samples incubated for 72 hours did not show any signs of cytotoxicity. The glove is non-cytotoxic to L-292 cell lines.
ISO 10993-10: 2010 Biological Evaluation of Medical Devices- Test for Irritation and Skin Sensitization- part 10: Tests for Intracutaneous Reactivity
Purpose: The test article identified below was evaluated for intracutaneous reactivity potential on single topical application.
Results: Under the conditions of this study, there was no erythema and no edema. The glove is considered a non-irritant.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
Purpose: This standard is designed to determine the amount of residual powder (or filter-retained mass) found on medical gloves.
Results: Requirement met.
ASTM D5151 06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves.
Purpose: This test method covers the detection of holes in medical gloves.
Results: Requirement met.
Summary of Clinical Performance Test
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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 | Finger | |||
| 0.10\u00b10.02 | Palm | |||||
| 0.08\u00b10.02 | Cuff | |||||
| 0.06\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 and
Parameters | Proposed Device:
Powder Free Nitrile
Examination Gloves
(Blue) | Predicate Device:
Powder Free Nitrile
Examination Gloves
(White, Cobalt Blue,
Black, Ice Blue) | Comparison |
|-----------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------|
| 510(k) number | K211457 | K150340 | Different |
| Product Code | LZA | LZA | Same |
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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. Ambidextrous |
- Finger Textured | 1. Ambidextrous
- Finger Textured | Same |
| Color | Blue | White, Cobalt Blue, Black & Ice Blue | Different
Colors |
Table 4: Device Dimension Comparison Table
| Proposed Device:
Powder Free Nitrile
Examination 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 Nitrile | |||||||
| Examination 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 |
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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 and
Parameters | Proposed Device:
Powder Free Nitrile
Examination Gloves
(Blue)
(K211457) | Predicate Device:
Powder Free Nitrile
Examination
Gloves (White,
Cobalt Blue, Black,
Ice Blue) (K150340) | Comparison |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Tensile Strength
(before age)
Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement of
Tensile Strength under
ASTM D6319 |
| Tensile Strength (after
age) Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement of
Tensile Strength under
ASTM D6319 |
| Ultimate Elongation
(before age) Minimum
14 MPa | Min 500% | Min 500% | Meeting requirement of
elongation under ASTM
D6319 |
| Ultimate Elongation
(after age) Minimum 14
MPa | Min 400% | Min 400% | Meeting requirement of
elongation under ASTM
D6319 |
| Freedom of Holes Meet
AQL 2.5 at G1 | Meet AQL 1.5 with
G1 | Meet AQL 1.5 with
G1 | Meeting requirement of
freedom of holes under
ASTM D6319 |
| Residual powder test
(Less than 2mg / glove) | Average powder
residue for each size:
S: 0.30 mg/glove
M: 0.31 mg/glove
L: 0.45 mg/glove | Contained less than
2 mg/glove | Meeting requirement of
powder residue under
ASTM D6319 |
| Primary Skin Irritation
(Surface-contacting, less
than 24 hours
duration) | Under the conditions
of study, not an irritant | Under the conditions
of study, not an
irritant | Yes, both are tested to be
non-irritant |
| Dermal Sensitization
(Surface-contacting, less
than 24 hours
duration) | Under the conditions
of study, not a
sensitizer | Under the conditions
of study, not a
sensitizer | Yes, both are tested to be
non-sensitizer |
| In Vitro Cytotoxicity
(Surface-contacting, less
than 24 hours duration) | Under the conditions
of study, non-
cytotoxic | Not tested | The predicate device was
not tested for In Vitro
Cytotoxicity |
| Intracutaneous Reactivity | Under the conditions
of study, not an irritant | Not tested | The predicate device was
not tested for
Intracutaneous reactivity |
Table 5: Device Performance Comparison
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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 10993-10:2010 | |||
| Biological Evaluation of Medical Devices - | |||
| Part 10: Tests for Irritation and Skin | |||
| Sensitization. | This part of ISO 10993 assesses possible | ||
| contact hazards from | |||
| chemicals released | |||
| from medical devices, | |||
| which may produce | |||
| skin and mucosal | |||
| irritation, eye irritation | |||
| or skin sensitization. | Skin Sensitization Test: | ||
| Provided gradesLess than 1.0 (in vitro cytotoxicity of | |||
| medical devices. | For biocompatible, if | ||
| the number of viable | |||
| L929 mouse fibroblasts | |||
| counts in direct method | |||
| should be more than | |||
| 70% to pass the test. | The study finds that the cells | ||
| beneath the test samples | |||
| incubated for 72 hours did not | |||
| show any signs of | |||
| cytotoxicity. The glove is | |||
| non-cytotoxic to L-292 cell | |||
| lines. | |||
| ISO 10993-10: 2010 | |||
| Biological Evaluation | |||
| of Medical Devices- | |||
| Test for Irritation and | |||
| Skin Sensitization— | |||
| part | |||
| 10: Tests for systemic | |||
| toxicity | The test article | ||
| identified below was | |||
| evaluated for | |||
| intracutaneous | |||
| reactivity potential on | |||
| single topical | |||
| application. | The requirements of the | ||
| test were met if the | |||
| difference between the | |||
| test extract mean score | |||
| and control mean score | |||
| was 1.0 or less. |
0-No erythema
/oedema
1-Slight erythema
/oedema
2-Well defined
erythema /oedema
3-Moderate erythema
/oedema
4-Severe erythema
/oedema | Under the conditions of this
study, there was no erythema
and no edema. The glove is
considered a non- irritant. |
| ASTM D6124-06
(Reapproved 2017),
Standard Test Method
for Residual Powder
on Medical Gloves | This standard is
designed to determine
the amount of residual
powder (or filter-
retained mass) found
on medical gloves | Powder residue limit of
2.0 mg | Requirement met. |
| ASTM D5151 06
(Reapproved 2015),
Standard Test Method
for Detection of Holes
in Medical Gloves. | This test method
covers the detection
of holes in medical
gloves. | Samples number: 500
gloves
AQL: 2.5 (ISO 2859)
Criterion ≤ 21 gloves
for 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.