Black Nitrile Powder Free Patient Examination Glove, Non Sterile

K233740 · W.A. Rubbermate Co., Ltd. · LZA · Feb 13, 2024 · General Hospital

Device Facts

• Record ID: K233740
• Device Name: Black Nitrile Powder Free Patient Examination Glove, Non Sterile
• Applicant: W.A. Rubbermate Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Feb 13, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A nitrile patient examination glove 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.

Device Story

Disposable, non-sterile, ambidextrous nitrile rubber examination glove; worn on examiner's hand or finger; prevents cross-contamination between patient and examiner; used in clinical settings; no electronic components or software; physical barrier function; provides protection during medical examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D412 (tensile properties), ASTM D3767 (dimensions), ASTM D5151 (watertightness), and ASTM D6124 (residual powder). Biocompatibility confirmed via ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (acute systemic toxicity).

Technological Characteristics

Nitrile rubber; non-sterile; ambidextrous; powder-free; surface treated for donning; sizes XS-XXL. Complies with ASTM D6319, ASTM D412, ASTM D5151, and ASTM D6124. Biocompatibility per ISO 10993-10 and ISO 10993-11.

Indications for Use

Indicated for use as a disposable, non-sterile, ambidextrous nitrile rubber glove worn by medical examiners on hands or fingers to prevent cross-contamination between patient and examiner.

Regulatory Classification

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.

Predicate Devices

• Disposable Powder Free Nitrile Examination Glove, Black Color (K190942)

Submission Summary (Full Text)

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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 13, 2024

W.A. Rubbermate Co., Ltd. Prachai Kongwaree President 4 Ramkhamhaeng 19 (Chareonploy) Huamark Bangkok, 10240 Thailand

Re: K233740

Trade/Device Name: Black Nitrile Powder Free Patient Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 15, 2023 Received: November 22, 2023

Dear Prachai Kongwaree:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Allan Guan-S

For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices

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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

Submission Number (if known)

K233740

Device Name

Black Nitrile Powder Free Patient Examination Glove, Non Sterile

Indications for Use (Describe)

A nitrile patient examination glove 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.

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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# 510k Summary (K233740)

(As Required by 21 CFR 807.92)

# 1.0 Submitter:

| Name | Prachai Kongwaree, President, W.A. Rubbermate<br>CO., LTD.<br><b>W.A. RUBBERMATE CO., LTD.</b> |
|--------------------------|------------------------------------------------------------------------------------------------|
| Address | 4 Ramkhamhaeng 19 (Chareonploy)<br>Huamark,<br>Bangkok, Thailand 10240 |
| Phone No. | 66-2-3189442 |
| Date of Summary Prepared | 13 February 2024 |

# 2.0 ldentification of the subject device:

| Trade Name: | : Black Nitrile Powder Free Patient Examination Glove, Non<br>Sterile |
|-----------------------|-----------------------------------------------------------------------|
| Common Name: | : Patient Examination Gloves |
| Classification Name : | : Non-powdered patient examination glove |
| Device Classification | : I |
| Regulation Number : | : 21 CFR 880.6250 |
| Product Code | : LZA |

### 3.0 Predicate Device:

# K190942

Trade Name : Disposable Powder Free Nitrile Examination Glove, Black Color Company: Ever Growth (Vietnam) Co., Ltd

# 4.0 Description of The Subject Device:

Black Nitrile Powder Free Patient Examination Glove, Non Sterile is manufactured from nitrile rubber. Inner surface of gloves undergoes a surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.

# 5.0 Indication for use:

A nitrile patient examination glove 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.

# 6.0 Comparison of the Technological Characteristics of the Device:

The Black Nitrile Powder Free Patient Examination Gloves, Non Sterile are summarized with the following technological characteristics compared to ASTM D6319 as shown in Table 1

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| CHARACTERISTICS | STANDARDS | PREDICATE | DEVICE PERFORMANCE | CURRENT | COMPARISON ANALYSIS |
|-----------------------------------------------------------|----------------------------------------------------|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| 510(k) Number | - | K190942 | | K233740 | Different |
| Manufacturer(s) | - | Ever Growth (Vietnam) Co., Ltd | | W.A. Rubbermate CO., LTD. | Same |
| Material | ASTM D6319-19 | Nitrile | | Nitrile | Same |
| Color | - | Black | | Black | Same |
| Sterility | - | Non-Sterile | | Non-Sterile | Same |
| Handedness | - | Ambidextrous | | Ambidextrous | Same |
| Physical Properties | ASTM D6319-19 | | | | |
| Before Aging<br>Tensile Strength:<br>Ultimate Elongation: | | 14Mpa, min<br>500% min | | 15.7 – 39.8 Mpa<br>550 - 620% | Different but within the ASTM standard |
| After Aging Tensile<br>Strength:<br>Ultimate Elongation: | | 14Mpa, min<br>400% min | | 17.0 – 40.6 Mpa<br>460 - 600% | Different but within the ASTM standard |
| | | | | | |
| Length | ASTM D6319-19 | 230 mm min | | Min 240 | Different but within the ASTM standard |
| Thickness:<br>- Finger<br>- Palm | ASTM D6319-19 | 0.05mm min<br>0.05mm min | | Min 0.13mm for (XS, S, M, L, XL, XXL)<br>Min 0.09mm for (XS, S, M, L, XL, XXL) | Different but within the ASTM standard |
| Powder Free | ASTM D6124 | < 2mg per glove | | Below 2mg of residual powder | Similar |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | |
| | | PREDICATE | CURRENT | COMPARISON ANALYSIS | |
| | | BLACK | BLACK | | |
| | Primary Skin Irritation<br>- ISO 10993-10:2021 (E) | Passes | Under the conditions of this study, the test material induced negligible irritation in a rabbit skin single-exposure test. | Same | |
| Biocompatibility | Dermal Sensitization-<br>ISO 10993-10: 2010 (E) | Passes | Under the conditions of this study, the frequency of positive challenge results in sample extract and Negative control animals are 0%, the Positive control is 100%, where the test material did not produce a skin sensitization effect in the guinea pigs. | Same | |
| | Cytotoxicity - MEM<br>Elution, ISO 10993-5: 2009 | Passes | The study was conducted as the alternative to the cytotoxic test | Different - but an additional test of Acute Systemic Toxicity is conducted and passed | |
| | Acute Systemic<br>Toxicity, ISO 10993-11:2017 (E) | Not Tested | Under the conditions of this study, the test item did not induce any acute systemic toxicity reaction in mice. | Different. The subject glove was tested using a systemic toxicity test and passed, but the Predicate did not have the test performed | |
| CHARACTERISTICS | STANDARDS | | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE<br>BLACK | CURRENT<br>BLACK | | |
| Watertight (1000ml) | ASTM D5151:2019 | | In accordance with ASTM D6319-10<br>and ASTM D5151-06 (Reapproved<br>2011), G-1, AQL 2.5 | Tested in accordance with ASTM<br>D5151 (Reapproved 2019) with<br>acceptable results at an AQL 2.5 | Similar |
| Intended use | - | | The Nitrile Powder Free Patient<br>examination glove is a non-sterile<br>disposable device intended for<br>medical purpose that is worn on<br>the examiners hands or finger to<br>prevent contamination between<br>patient and examiner. | A nitrile patient examination glove<br>is a disposable device made of<br>nitrile rubber intended for medical<br>purposes that is worn on the<br>examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. | Similar |
| Size | Medical Glove<br>Guidance Manual -<br>Labeling | | Extra Small<br>Small<br>Medium<br>Large<br>X Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large<br>Extra Extra Large | Similar, with and<br>addition of size Extra<br>Extra Large |
| Single use | Medical Glove<br>Guidance Manual -<br>Labeling | | Single Use | Single Use | Same |

Table 1

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# Summary of Non-Clinical Testing 7.0

The performance test data of the non-clinical tests for this powder free nitrile examination glove is summarized as per below

| Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | | Results | | Status | |
|------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------|----------------|--------------|------------------------------------------------------------------------|--------------------------------------------------------------------------|------|
| | | | Before<br>aging | After<br>aging | Before aging | After aging | | |
| Physical<br>Properties | ASTM D412<br>(Standard Test Method<br>for Vulcanized Rubber<br>and Thermoplastic<br>Elastomers-Tension) | To evaluate the<br>tensile (tension)<br>properties of the<br>glove. | Tensile<br>strength | Min 14.0 MPa | Min 14.0 MPa | XS - 22.3<br>S – 15.7<br>M - 27.1<br>L – 24.8<br>XL-30.1<br>XXL – 23.3 | XS - 21.2<br>S – 17.0<br>M - 30.7<br>L - 24.2<br>XL – 23.3<br>XXL - 23.5 | Pass |
| | | | Ultimate<br>elongation | Min<br>500% | Min<br>400% | XS - 560<br>S - 540<br>M - 540<br>L - 540<br>XL - 560<br>XXL - 540 | XS - 560<br>S - 500<br>M - 500<br>L - 520<br>XL - 460<br>XXL - 520 | Pass |

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| Test Method | Standard | Purpose of Testing | Glove Size | Acceptance Criteria | | | | Results | | | Status | |
|-------------|------------------------------------------------------------------|----------------------------------------------------|------------|---------------------|---------------------|-------|-------------------|-----------|---------|-------|---------|------|
| Dimension | ASTM D3767 Standard Practice for Rubber—Measurementof Dimensions | To measure the length, width and thickness ofglove | X-Small | Length | Min 220 mm | Width | 70 ± 10 mm | Length | 240 mm | Width | 76.0 mm | Pass |
| | | | | Thickness | Finger - min 0.05mm | | Palm - min 0.05mm | Thickness | 0.13 mm | | Pass | |
| | | | Small | Length | Min 220 mm | Width | 80 ± 10 mm | Length | 241 mm | Width | 83.0 mm | Pass |
| | | | | Thickness | Finger - min 0.05mm | | Palm - min 0.05mm | Thickness | 0.14 mm | | Pass | |
| | | | Medium | Length | Min 230 mm | Width | 95 ± 10 mm | Length | 241 mm | Width | 95.0 mm | Pass |
| | | | | Thickness | Finger - min 0.05mm | | Palm - min 0.05mm | Thickness | 0.13 mm | | Pass | |
| | | | Large | Length | Min 230 mm | Width | 110 ± 10 mm | Length | 241 mm | Width | 105 mm | Pass |
| | | | | Thickness | Finger - min 0.05mm | | Palm - min 0.05mm | Thickness | 0.09 mm | | Pass | |

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| | Thickness | Length | Width | Thickness | Length | Width | Thickness |
|----------|------------------------------------------|------------|-----------------|------------------------------------------|------------|-----------------|------------------------------------------|
| | Pass | Pass | Pass | Pass | Pass | Pass | Pass |
| | 0.13 mm | 240 mm | 110 mm | 0.14 mm | 240 mm | 121 mm | 0.13 mm |
| X-Large | Finger - min 0.05mm<br>Palm - min 0.05mm | Min 230 mm | $120 \pm 10$ mm | Finger - min 0.05mm<br>Palm - min 0.05mm | Min 230 mm | $130 \pm 10$ mm | Finger - min 0.05mm<br>Palm - min 0.05mm |
| XX-Large | | | | | | | |

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| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | Status |
|--------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Watertight | ASTM D5151<br>(Standard Test<br>Method for<br>Detection of Holesin<br>Medical Gloves) | To detect holes<br>that leak water and<br>thereby<br>compromise the<br>usefulness of the<br>glove. | Sample size: 200 pcs<br>AQL: 2.5, Acceptance No. 10<br><br>The batch size for this sampling<br>is 35,001 to 150,000. Hence,<br>according to the single<br>sampling plan GI, the<br>sample to be drawn is<br>under code L equivalent to<br>200 pieces with accept 10<br>and reject 11 to be<br>accepted under AQL 2.5 | For Size XS, during the test, 1<br>piece was found with leaks.<br>Hence it falls within the<br>acceptance criteria.<br><br>For Size S, during the test, 0<br>piece was found with leaks.<br>Hence it falls within the<br>acceptance criteria.<br><br>For Size M, during the test, 0<br>piece was found with leaks.<br>Hence it falls within the<br>acceptance criteria.<br><br>For Size L, during the test, 1<br>piece was found with leaks.<br>Hence it falls within the<br>acceptance criteria.<br><br>For Size XL, during the test, 1<br>piece was found with leaks.<br>Hence it falls within the<br>acceptance criteria.<br><br>For Size XXL, during the test, 3<br>piece was found with leaks.<br>Hence it falls within the<br>acceptance criteria | Pass |
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
| Residual<br>Powder | ASTM D6124<br>(Standard Test Method<br>for Residual Powder on<br>Medical Gloves) | To determine the<br>amount of residual<br>and non-powder<br>solids found on<br>gloves | Less than 2 mg per glove | Sample size : 5 pcs<br>Result XS :0.26mg/glove<br>Result S :0.50mg/glove<br>Result M :0.16mg/glove<br>Result L :0.52mg/glove<br>Result XL :0.46mg/glove<br>Result XXL :0.48mg/glove | Pass |
| compatibility | Primary Skin<br>Irritation - ISO<br>10993-10:2021<br>(E) | Evaluate the<br>possibility of skin<br>irritation after single<br>topical applications<br>of the test sample<br>extracts on the skin<br>of test subjects. | Observation of skin reaction for<br>erythema and oedema on test<br>subject | Under the conditions of this study,<br>the test material induced<br>negligible irritation in a rabbit skin<br>single-exposure test. | Pass |
| | Dermal Sensitization<br>ISO 10993-10: 2010<br>(E) | To evaluate<br>sensitization<br>(maximization test)<br>to evaluate<br>possibility of skin<br>sensitization after<br>topical applications<br>of the test sample<br>extracts on the test<br>subjects | Observation of skin sites for<br>erythema and oedema on test and<br>control test subjects as per<br>Magnusson and Klingman<br>Grading. | Under the conditions of this study,<br>the frequency of positive<br>challenge results in sample<br>extract and Negative control<br>animals are 0%, the Positive<br>control is 100%, where the test<br>material did not produce a skin<br>sensitization effect in the guinea<br>pigs | Pass |
| | Acute Systemic<br>Toxicity, ISO 10993-<br>11:2017 (Ε) | Evaluate the acute<br>systemic adverse<br>reactions after being<br>injected into test<br>subjects | No toxicity indication or death in<br>the animal subjected to study. | Under the conditions of this study,<br>the test item did not induce any<br>acute systemic toxicity reaction in<br>mice. | Pass |

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The following standards were followed to carry out the above testing:

- ASTM D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-O Tension
- ASTM D573 Test Method for Rubber-Deterioration in an Air Oven x ASTM D3578 O Specification for Rubber Examination Gloves
- ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical o Application
- ASTM D5151 Test Method for Detection of Holes in Medical Gloves O
- O ASTM D6124 Test Method for Residual Powder on Medical Gloves
- ISO 2859 Sampling Procedures and Tables for Inspection by Attributes Test results show O that under the conditions of the testing, there is no difference inphysical attributes between the proposed device and the predicate device.
- Biocompatibility Testing utilizing: ISO 10993 Biological Evaluation of Medical Devices: O
- . ISO 10993 - Part 10: Tests for Irritation and Sensitization. Both Skin Irritation and Dermal Magnuson/Kligman Sensitization performed.
- . ISO 10993 - Part 11: Tests for assessment of Systemic Toxicity

# 8.0 Summary of Clinical Testing:

No clinical studies are included in this submission.

# Conclusion

The conclusion drawn from the non-clinical tests demonstrates that the subject "Black 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 device K190942.