(97 days)
A 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. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile Tested for use with Chemotherapy Drugs meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
The provided document is a 510(k) premarket notification for a medical device (Blue Nitrile Powder Free Patient Examination Glove) and does not describe a study involving an AI/Machine Learning enabled device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, sample sizes, expert involvement, or MRMC studies for an AI device.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of physical properties, dimensions, watertightness, residual powder, and permeation to chemotherapy drugs.
However, to answer your request to the best of my ability based on the provided document and assuming the "device" refers to the Blue Nitrile Powder Free Patient Examination Glove, here's an interpretation of the relevant information provided:
Since this document pertains to a medical glove and not an AI/Machine Learning enabled device, the requested information regarding AI-specific criteria (e.g., human-in-the-loop, expert consensus for AI ground truth, MRMC studies) is not applicable and hence, not present in the provided text.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance standards and non-clinical tests conducted to demonstrate the safety and effectiveness of the medical glove.
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are generally based on ASTM standards (e.g., ASTM D6319, ASTM D5151, ASTM D6124) and outlined in the "Summary of Non-Clinical Testing 7.0" section, particularly in the tables on pages 11-14.
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance (Current Blue) | Status |
|---|---|---|---|---|
| Physical Properties | ASTM D412 | |||
| Before Aging: Tensile Strength | - | Min 14.0 MPa | 31.2 MPa | Pass |
| Before Aging: Ultimate Elongation | - | Min 500% | 594% | Pass |
| After Aging: Tensile Strength | - | Min 14.0 MPa | 34.7 MPa | Pass |
| After Aging: Ultimate Elongation | - | Min 400% | 553% | Pass |
| Dimensions (Example: X-Small) | ASTM D3767 | |||
| Length (X-Small) | - | Min 240 mm | 250 mm | Pass |
| Width (X-Small) | - | 70 ± 10 mm | 78.0 mm | Pass |
| Thickness Finger (X-Small) | - | Min 0.05mm | 0.10 mm | Pass |
| Thickness Palm (X-Small) | - | Min 0.05mm | 0.07 mm | Pass |
| Watertight | ASTM D5151 | Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 | 1 piece found with leaks (within acceptance criteria) | Pass |
| Residual Powder | ASTM D6124 | Less than 2 mg per glove | 0.26 mg/glove | Pass |
| Chemotherapy Drug Permeation | ASTM D6978-05(2019) (Minimum Breakthrough Detection Time in Minutes) | Varies by drug type (Implicitly, the device must meet or exceed predicate performance or established safety thresholds) | Values as listed in "Indications for Use" and "Table 1" (e.g., Carmustine: 23.0 min, Thiotepa: 98.8 min, others > 240 min) | Pass (compared to predicate) |
| Biocompatibility | ISO 10993-10, ISO 10993-5, ISO 10993-11 | Non-irritant, non-sensitizer, and no systemic toxicity. Cytotoxicity may be noted but compensated by other tests. | Non-irritant, non-sensitizer, no systemic toxicity. Cytotoxic effect noted, but acute systemic toxicity test passed. | Similar to predicate / Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document clearly states the sample sizes for certain tests:
- Watertight Test: 315 pieces (gloves) were used for this specific test.
- Residual Powder Test: 5 pieces (gloves) were used.
- Physical Properties & Dimensions: Specific sample sizes are not explicitly stated for these tests, but standards like ASTM D412 and D3767 would define the required sample sizes.
- Chemotherapy Drug Permeation: The specific number of gloves tested per drug type is not listed, but the test methodology (ASTM D6978-05(2019)) typically specifies this. The results are average breakthrough times.
Data Provenance: The tests were conducted by Rimba Glove Sdn Bhd, located in Perak, Malaysia (Submitter information on page 5). The data is non-clinical performance data for the device itself. It is inherently prospective testing of manufactured samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This question is not applicable as the "ground truth" for this device is established by physical measurement and chemical analysis against specified ASTM (American Society for Testing and Materials) standards. There are no human experts involved in "establishing ground truth" in the way a radiologist reviews images for an AI algorithm. The tests are objective laboratory measurements.
4. Adjudication Method for the Test Set:
Not applicable. This concept applies to subjective assessments, often in an AI context where multiple human readers disagree. Here, the tests are objective laboratory measurements (e.g., tensile strength, water leak detection, chemical permeation time).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is a medical device (glove), not an AI/Machine Learning enabled device. MRMC studies are specific to evaluating diagnostic accuracy, often comparing human performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/Machine Learning enabled device. The "standalone performance" is the performance of the glove itself against the defined physical and chemical standards.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance is based on objective, measurable criteria defined by international standards (ASTM, ISO) for medical gloves and their material properties. This includes:
- Physical properties (tensile strength, elongation)
- Dimensional measurements (length, width, thickness)
- Integrity (watertightness)
- Chemical residue (residual powder)
- Permeation resistance to chemotherapy drugs.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/Machine Learning device that requires a training set. The device manufacturing processes are subject to Quality System Regulations (21 CFR Part 820), not machine learning training.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" for this type of medical device.
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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.
February 8, 2022
Rimba Glove SDN BHD % Michael Woude U.S Agent Emergo Global Representation LLC 2500 Bee Cave Road Bldg 1, Suite 300 Austin, Texas 78746
Re: K212898
Trade/Device Name: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC
Dear Michael Woude:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 16, 2021. Specifically, FDA is updating this SE Letter to address a typo in the sponsor name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. Clarance Murray, OHT4: Office of Surgical and Infection Control Devices, 301-796-0870, Clarence.Murray@fda.hhs.gov.
Image /page/0/Picture/8 description: The image shows the text "Sincerely," followed by the name "Liqun Zhao -S". The text is written in a clear, legible font and is likely part of a signature or closing statement. The name is slightly larger than the word "Sincerely,". The image appears to be a cropped portion of a larger document.
For Clarence W. Murray, III, Ph.D 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
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December 16, 2021
Rimba Glove SND BHD % Michael Woude U.S Agent Emergo Global Representation LLC 2500 Bee Cave Road Bldg 1. Suite 300 Austin, Texas 78746
Re: K212898
Trade/Device Name: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: September 4, 2021 Received: September 10, 2021
Dear Michael Woude:
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.
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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 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 (QS) 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 medical devices and radiation-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).
Sincerelv.
Liqun Zhao -S
For Clarance W. Murray III, Ph.D. 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
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Indications for Use
510(k) Number (if known) K212898
Device Name
BLUE NITRILE POWDER FREE PATIENT EXAMINATION GLOVE, NON STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Indications for Use (Describe)
A 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.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Breakthrough Detection Time in Minutes |
|---|---|
| *Carmustine (BCNU) | 23.0 |
| Cisplatin | > 240 |
| Cyclophosphamide (Cytoxan) | > 240 |
| Dacarbazine | > 240 |
| Doxorubicin HCI | > 240 |
| Etoposide | > 240 |
| Fluorouracil | > 240 |
| Ifosfamide | > 240 |
| Methotrexate | > 240 |
| Mitomycin C | > 240 |
| Mitoxantrone | > 240 |
| Paclitaxel | > 240 |
| *Thiotepa | 98.8 |
| Vincristine Sulfate | > 240 |
*CAUTION: Testing showed an average breakthrough time of 23.0 minutes for Carmustine and an average breakthrough time of 98.9 minutes for Thiotepa.
** WARNING: DO NOT USE WITH CARMUSTINE.
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.
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1.0 Submitter:
| Name: | Zahari Bin Darus |
|---|---|
| Address: | Rimba Glove Sdn BhdPlot 37, Medan Tasek, Tasek Industrial Estate, 31400 Ipoh,Perak, Malaysia |
| Phone No.: | +605-5483688 |
| Fax No.: | +605-5481688 |
Date of Summary Prepared: 20th August 2021 (REVISED DATE: 7th Dec 2021)
Identification of the subject device: 2.0
| Trade Name | : Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for use with Chemotherapy Drugs. |
|---|---|
| Common Name | : Patient Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Device Classification | : 1 |
| Regulation Number | : 21 CFR 880.6250 |
| Product Code | : LZA, LZC |
3.0 Predicate Device:
K210944
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue).
Company: Harbour Health LLC.
4.0 Description of The Device:
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile Tested for use with Chemotherapy Drugs meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from nitrile rubber. Inner surface of gloves underqoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
5.0 Indication for use:
A patient examination qlove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device has also been tested for use with Chemotherapy Drugs per ASTM D 6978-5(2019). WARNING: DO NOT USE WITH CARMUSTINE.
6.0 Comparison of the Technological Characteristics of the Device:
The Blue Nitrile Powder Free Patient Examination Glove. Non-Sterile tested for use with chemotherapy drugs are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1.
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Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
|---|---|---|---|---|
| PREDICATEBLUE | CURRENTBLUE | |||
| 510(k) Number | - | K210944 | K212898 | |
| Manufacturer(s) | - | Harbour Health LLC, New Jersey07059. | Rimba Glove Sdn Bhd | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger texture | Finger Texture | Same |
| Physical Properties | ASTM D6319 | |||
| Before AgingTensile Strength:Ultimate Elongation: | ≥ 14Mpa500% | 31.2Mpa594% | Different butwithin the ASTMstandard | |
| After AgingTensile Strength:Ultimate Elongation: | ≥ 14Mpa400% | 34.7Mpa553% | Different butwithin the ASTMstandard | |
| Thickness:- Finger- Palm | ASTM D6319 | 0.05mm0.05mm | 0.10mm0.07mm | Different butwithin the ASTMstandard |
| Powder Free | ASTM D6124 | ≤ 2 mg/glove | 0.26 mg/glove | Different butwithin the ASTMstandard |
| DEVICE PERFORMANCE | ||||
| CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISONANALYSIS |
| BLUE | BLUE | |||
| Primary Skin Irritation- ISO 10993-10:2010(E) & ConsumerProduct SafetyCommission Title 16.Chapter II, Part 1500 | Under the condition of study,the device is a non-irritant | Under the conditions of study,the test material did not causean irritant response. ThePrimary Irritant ResponseCategory is deemed 'Negligible' | Similar | |
| Dermal Sensitization-ISO 10993-10: 2010(E) & ConsumerProduct SafetyCommission, Title 16,Chapter II, Part1500.3 (c) (4) | Under the conditions of thestudy, the device is a non-sensitizer | Under the conditions of study,the test material did notproduce a skin sensitizationeffect in the guinea pigs. | Similar | |
| Biocompatibility | Cytotoxicity - MEMElution, ISO 10993-5:2009 (E) | Under the conditions of thestudy, the device is potentiallycytotoxic. | Under the conditions of study,the test material demonstrateda cytotoxic effect under thecondition of this study.Additional test i.e. AcuteSystemic Toxicity was tested. | Similar |
| DEVICE PERFORMANCE | ||||
| CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISONANALYSIS |
| BLUE | BLUE | |||
| Biocompatibility | Acute SystemicToxicity,ISO 10993-11:2017 (Ε) | Under the conditions of study, thedevice does not elicit a systemictoxicity response in the modelanimal. | Under the conditions of study,the test item did not induceany systemic toxicity in Swissalbino mice. | Similar |
| Watertight (1000ml) | ASTM D 6319-19ASTM D5151-19 | Complies with ASTM D6319-19 andASTM D5151-19, G-1, AQL 2.5 | Gloves passed AQL 1.5 | Different but wellwithin the ASTMD6319-19 |
| Intended use | - | The Harbour Health Powder FreeNitrile Examination Glove, Blue(Tested for use with ChemotherapyDrugs) is a disposable deviceintended for medical purposes that isworn on the examiner's hand toprevent contamination betweenpatient and examiner. The proposeddevice was tested for use withChemotherapy drugs per ASTMD6978-05(2019), Standard Practicefor Assessment of Medical Gloves toPermeation by Chemotherapy drugs. | A patient examination glove isa disposable device made ofnitrile rubber intended formedical purposes that is wornon the examiner's hand orfinger to prevent contaminationbetween patient and examiner.The device has also beentested for use withChemotherapy Drugs per ASTMD 6978-5(2019) | Same |
| Size | Medical GloveGuidanceManual -Labeling | SmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Similar |
| Single use | Medical GloveGuidanceManual -Labeling | Single Use | Single Use | Same |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
| PREDICATE | CURRENT | |||
| BLUE | BLUE | |||
| Chemotherapy DrugsPermeation Test | Minimum BreakthroughDetection Times in Minutes | Minimum BreakthroughDetection Times in Minutes | ||
| Carmustine (BCNU) -3.3 mg/ml | 14.5 | 23.0 | Different in theresult | |
| Cisplatin - 1.0 mg/ml | >240 | >240 | Same | |
| Cyclophosphamide (Cytoxan)- 20.0 mg/ml | >240 | >240 | Same | |
| Dacarbazine – 10.0 mg/ml | >240 | >240 | Same | |
| Doxorubicin HCI – 2.0 mg/ml | >240 | >240 | Same | |
| Etoposide - 20.0 mg/ml | >240 | >240 | Same | |
| Fluorouracil – 50.0 mg/ml | ASTM D6879-5(2019) | >240 | >240 | Same |
| Ifosfamide – 50.0 mg/ml | >240 | >240 | Same | |
| Methotrexate - 25 mg/ml | >240 | >240 | Same | |
| Mitomycin C - 0.5 mg/ml | >240 | >240 | Same | |
| Mitoxantrone – 2 mg/ml | >240 | >240 | Same | |
| Paclitaxel - 6.0 mg/ml | >240 | >240 | Same | |
| Thiotepa – 10 mg/ml | 47.4 | 98.8 | Different in theresult | |
| Vincristine Sulfate - 1 mg/ml | >240 | >240 | Same |
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There are no significant differences between the two products and they are the same or similar in terms of intended use, materials design, physical properties, thickness and biocompatibility test.
Summary of Non-Clinical Testing 7.0
The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.
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| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |||
|---|---|---|---|---|---|---|---|---|
| Before aging | After aging | Before aging | After aging | |||||
| Physical Properties | ASTM D412(Standard Test Method forVulcanized Rubber and ThermoplasticElastomers-Tension) | To evaluate the tensile (tension) properties of glove. | Tensile strength | Min 14.0 MPa | Min 14.0 MPa | 31.2Mpa | 34.7Mpa | Pass |
| Ultimate elongation | Min 500% | Min 400% | 594% | 553% | Pass |
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| TestMethod | Standard | Purpose ofTesting | GloveSize | Acceptance Criteria | Results | Status | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Dimension | ASTM D3767Standard Practice forRubber—Measurementof Dimensions | To measure thelength, widthand thicknessof glove | X-Small | Length | Min 240 mm | Length | 250 mm | Pass | ||
| Width | $70 \pm 10$ mm | Width | 78.0 mm | Pass | ||||||
| Thickness | Finger | min 0.05mm | Thickness | 0.10 | mm | Pass | ||||
| Palm | min 0.05mm | 0.07 mm | ||||||||
| Small | Length | Min 240 mm | Length | 250 mm | Pass | |||||
| Width | $80 \pm 10$ mm | Width | 88.0 mm | Pass | ||||||
| Thickness | Finger | min 0.05mm | Thickness | 0.10 | mm | Pass | ||||
| Palm | min 0.05mm | 0.07 mm | ||||||||
| Medium | Length | Min 240 mm | Length | 250 mm | Pass | |||||
| Width | $95 \pm 10$ mm | Width | 98.0 mm | Pass | ||||||
| Thickness | Finger | min 0.05mm | Thickness | 0.10 | mm | Pass | ||||
| Palm | min 0.05mm | 0.07 mm | ||||||||
| Large | Length | Min 240 mm | Length | 250 mm | Pass | |||||
| Width | $110 \pm 10$ mm | Width | 108 mm | Pass |
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| Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass | ||||
|---|---|---|---|---|---|---|---|---|
| Palm – min 0.05mm | 0.07 mm | |||||||
| X-Large | Length | Min 240 mm | Length | 250 mm | Pass | |||
| Width | $120 \pm 10$ mm | Width | 118 mm | Pass | ||||
| Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass | ||||
| Palm – min 0.05mm | 0.07 mm |
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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Watertight | ASTM D5151(Standard TestMethod forDetection of Holesin Medical Gloves) | To detect holesthat leak waterand therebycompromise theusefulness of theglove. | Sample size: 315 pcsInspection level: G1AQL: 1.5, Acceptance No. 10 | The batch size for thissampling is 150,001 to500,000. Hence,according to the singlesampling plan GI, thesample to be drawn isunder code Mequivalent to 315pieces with accept 10and reject 11 to beaccepted under AQL1.5. During the test, 1piece was found withleaks. Hence it fallswithin the acceptancecriteria. | Pass |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| ResidualPowder | ASTM D6124(Standard TestMethod for ResidualPowder on MedicalGloves) | To determine theamount ofresidual powderand non-powdersolids found ongloves. | Less than 2 mg per glove | Sample size : 5 pcsRequirement : <2mg/gloveResult :0.26mg/glove | Pass |
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8.0 Summary of Clinical Testing:
No clinical study is included in this submission.
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K210944.
§ 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.