Blue Nitrile Powder Free Patient Examination Glove, Non Sterile

K222720 · Safeskin Retailing (Hk) Limited · LZA · Dec 3, 2022 · General Hospital

Device Facts

• Record ID: K222720
• Device Name: Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
• Applicant: Safeskin Retailing (Hk) Limited
• Product Code: LZA · General Hospital
• Decision Date: Dec 3, 2022
• 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 nitrile rubber examination glove; ambidextrous; non-sterile. Used by healthcare professionals in clinical settings to provide a physical barrier against contamination. Device is donned manually; smooth inner surface facilitates donning without lubricants. Provides protection during patient examinations. Benefits include reduced risk of cross-contamination between patient and examiner.

Clinical Evidence

No clinical data. Bench testing only, including physical properties (ASTM D412), dimensions (ASTM D3767), watertightness (ASTM D5151), residual powder (ASTM D6124), and biocompatibility (ISO 10993-10, ISO 10993-11).

Technological Characteristics

Material: Nitrile rubber. Form factor: Ambidextrous, powder-free, non-sterile. Standards: ASTM D6319 (specifications), ASTM D412 (tensile), ASTM D573 (aging), ASTM D3767 (dimensions), ASTM D5151 (watertightness), ASTM D6124 (residual powder).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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

• Blue Nitrile Examination Gloves Powder Free (K192333)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 3, 2022

Safeskin Retailing (HK) Limited % Stephan Toupan President Dawa Medical LLC 7320 NW 12th Street Suite 103 Miami, Florida 33126

Re: K222720

Trade/Device Name: Blue 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: September 5, 2022 Received: September 8, 2022

Dear Stephan Toupan:

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Bifeng Qian -S

Bifeng Qian, M.D., 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) K222720

Device Name BLUE 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) | |
|----------------------------------------------|-------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span> ☒ </span> </div> |

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# K222720 510(k) SUMMARY

This summary of 510(k) information is submitted in accordance with the requirements of 21 CFR 870.92.

| 1.0 | Submitter:<br>Name | : | Alvin Ho |
|-----|--------------------------|---|---------------------------------------------------------------------------------------------------------------|
| | Address | : | Safeskin Retailing (HK) Limited<br>26th Floor, Beautiful Group Tower, 77 Connaught Road<br>Central, Hong Kong |
| | Phone No. | : | [phone] |
| | Date of Summary Prepared | : | 18 Nov 2022 |

#### 2.0 ldentification of the subject device:

| Trade Name: | Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile |
|------------------------|-----------------------------------------------------------------|
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Classification: | 1 |
| Regulation Number: | 21 CFR 880.6250 |
| Product Code: | LZA |

#### 3.0 Predicate Device:

# K192333

Trade name: Blue Nitrile Examination Gloves Powder Free Company: JR Engineering and Medical Technologies (M) Sdn Bhd

#### 4.0 Description of The Subject Device:

Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface 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 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 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 with the predicate Device:

The Blue Nitrile Powder-Free Patient Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319or equivalent standards as shown in Table

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# Table 1

| | STANDARDS | DEVICE PERFORMANCE | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------------------------------------------|------------|-------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------|------------|---|--------------|--------------|------|--------------|---|-----|-----|------|---------------------|------------|--|--|--|-----------------------------------------------------------|--|-----------------|--------------------------------|----------------------------------------------|----------------------------------------------------------|--|-----------------|-------------------------------|------------------------------------------|--------------------------------|------------|--------------|----------------------------------------------------------------------|----------------------------------------------|---------------|------------|--------------|------------------------------|----------------------------------------------|
| CHARACTERISTICS | | PREDICATE | CURRENT | COMPARISON<br>ANALYSIS | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | BLUE | BLUE | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | - | K192333 | K222720 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Manufacturer(s) | - | JR Engineering & Medical Technologies<br>(M) Sdn Bhd. | Safeskin Retailing (HK) Limited | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Color | - | Blue | Blue | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sterility | - | Non-Sterile | Non-Sterile | Same | Handedness | - | Ambidextrous | Ambidextrous | Same | Product Code | - | LZA | LZA | Same | Physical Properties | ASTM D6319 | | | | Before Aging<br>Tensile Strength:<br>Ultimate Elongation: | | 25.6Mpa<br>868% | 28.0 – 32.8 Mpa<br>530 – 590 % | Different but<br>within the ASTM<br>standard | After Aging Tensile<br>Strength:<br>Ultimate Elongation: | | 22.0Mpa<br>828% | 30.9 – 35.1 Mpa<br>460 - 540% | Different but within the<br>ASTMstandard | Thickness:<br>- Finger<br>Palm | ASTM D6319 | 0.22mm0.20mm | Min 0.10mm for (XS, S, M, L, XL)<br>Min 0.06mm for (XS, S, M, L, XL) | Different but<br>within the ASTM<br>standard | - Powder Free | ASTM D6124 | 0.21mg/glove | Below 2mg of residual powder | Different but<br>within the ASTM<br>standard |
| Handedness | - | Ambidextrous | Ambidextrous | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Product Code | - | LZA | LZA | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Physical Properties | ASTM D6319 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Before Aging<br>Tensile Strength:<br>Ultimate Elongation: | | 25.6Mpa<br>868% | 28.0 – 32.8 Mpa<br>530 – 590 % | Different but<br>within the ASTM<br>standard | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| After Aging Tensile<br>Strength:<br>Ultimate Elongation: | | 22.0Mpa<br>828% | 30.9 – 35.1 Mpa<br>460 - 540% | Different but within the<br>ASTMstandard | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Thickness:<br>- Finger<br>Palm | ASTM D6319 | 0.22mm0.20mm | Min 0.10mm for (XS, S, M, L, XL)<br>Min 0.06mm for (XS, S, M, L, XL) | Different but<br>within the ASTM<br>standard | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| - Powder Free | ASTM D6124 | 0.21mg/glove | Below 2mg of residual powder | Different but<br>within the ASTM<br>standard | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| | | PREDICATE<br>BLUE | CURRENT<br>BLUE | |
| Biocompatibility | Primary Skin Irritation<br>- ISO 10993-10:2010<br>(E) & Consumer<br>Product Safety<br>Commission Title 16.<br>Chapter II, Part 1500 | Under the condition of study not<br>an irritant | Under conditions of this study, the<br>test material did not cause an<br>irritant response. The Primary<br>Irritant Response Category is<br>deemed 'Negligible' | Same |
| | Dermal Sensitization-<br>ISO 10993-10: 2010<br>(E) & Consumer Product<br>Safety Commission,<br>Title 16,Chapter II, Part<br>1500.3 (c) (4) | Under the condition of the<br>study not a sensitizer | Under conditions of this study,the<br>test material did not produce a skin<br>sensitization effect in the guinea<br>pigs. | Same |
| | Acute Systemic<br>Toxicity, ISO 10993-<br>11:2017 (E) | Under the conditions of study, the<br>device extracts do not pose a<br>systemic toxicity concern | Under conditions of this study,the<br>test item did not induce any<br>systemic toxicity in Swiss albino<br>mice. | Same |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE | CURRENT | |
| | | BLUE | BLUE | |
| Watertight (1000ml) | ASTM D5151:2019 | Gloves passes AQL 1.5 | Meets<br>● 21 CFR 800.20<br>● ASTM D6319-10<br>(Reapproved 2015)<br>Tested in accordance with ASTM<br>D5151 (Reapproved 2015) with<br>acceptable results at an AQL 1.5 | Different but within the<br>ASTM standard. |
| Intended use | – | JR MEDIC BLUE Nitrile Examination<br>Gloves Powder Free is disposable<br>devices intended for medical<br>purpose that are worn on the<br>examiners hand to prevent<br>contamination between patient and<br>examiner | A Nitrile patient examination glove is a<br>disposable device made of nitrile<br>rubber intended for medical purposes<br>that is worn on the examiner's hand or<br>finger to prevent contamination<br>between patient and examiner. | Same |
| Size | Medical Glove Guidance<br>Manual —Labeling | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Same |
| Single use | Medical Glove Guidance<br>Manual —Labeling | Single Use | Single Use | Same |

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#### 7.0 Summary of Non-Clinical Testing

| Test<br>Method | Standard | Purpose of Testing | | Acceptance Criteria | | Results | | Status |
|------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------|---------------------|-----------------|------------------------------------------------------------|------------------------------------------------------------|--------|
| 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 glove. | Tensile<br>strength | Before<br>aging | After<br>aging | Before<br>aging | After aging | Pass |
| | | | | Min 14.0<br>MPa | Min 14.0<br>MPa | XS - 28.1<br>S - 28.4<br>M - 29.2<br>L - 28.0<br>XL - 28.9 | XS - 31.2<br>S – 30.9<br>M - 32.3<br>L - 31.0<br>XL - 31.3 | |
| | | | Ultimate<br>elongation | Min<br>500% | Min<br>400% | XS - 540<br>S - 530<br>M - 550<br>L - 540<br>XL - 540 | XS - 460<br>S – 460<br>M - 470<br>L - 490<br>XL - 480 | Pass |

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<br>Method | Standard | Purpose of<br>Testing | Glove<br>Size | Acceptance Criteria | Results | Status | |
|----------------|----------------------------------------------------------------------------------|----------------------------------------------------------|---------------|------------------------------------------|----------------------|--------------------|------|
| Dimension | ASTM D3767<br>Standard<br>Practice for<br>Rubber—<br>Measurementof<br>Dimensions | To measure the<br>length, width and<br>thickness ofglove | X-Small | Length<br>Min 240 mm | Length<br>244 mm | Pass | |
| | | | | Width<br>$70 \pm 10$ mm | Width<br>74.0 mm | Pass | |
| | | | | Thickness<br>Finger – min 0.05mm | Thickness<br>0.10 mm | Pass | |
| | | | | Palm - min 0.05mm | 0.06 mm | | |
| | | | Small | Length<br>Min 240 mm | Length<br>242 mm | Pass | |
| | | | | Width<br>$80 \pm 10$ mm | Width<br>85.0 mm | Pass | |
| | | | | Thickness<br>Finger – min 0.05mm | Thickness<br>0.10 mm | Pass | |
| | | | | Palm - min 0.05mm | 0.06 mm | | |
| | | | Medium | Length<br>Min 240 mm | Length<br>242 mm | Pass | |
| | | | | Width<br>$95 \pm 10$ mm | Width<br>95.0 mm | Pass | |
| | | | | Thickness<br>Finger – min 0.05mm | Thickness<br>0.10 mm | Pass | |
| | | | | Palm - min 0.05mm | 0.06 mm | | |
| | | | Large | Length<br>Min 240 mm | Length<br>243 mm | Pass | |
| | | | | Width<br>$110 \pm 10$ mm | Width<br>106 mm | Pass | |
| | | | Thickness | Finger – min 0.05mm<br>Palm – min 0.05mm | Thickness | 0.10 mm<br>0.06 mm | Pass |
| | | X-Large | Length | Min 240 mm | Length | 244 mm | Pass |
| | | | Width | $120 \pm 10$ mm | Width | 115 mm | Pass |
| | | | Thickness | Finger – min 0.05mm<br>Palm – min 0.05mm | Thickness | 0.10 mm<br>0.06 mm | Pass |

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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: 315 pcs<br>Inspection level: G1<br>AQL: 1.5, Acceptance No. 10 | The batch size for this sampling<br>is 150,001 to500,000. Hence,<br>according to the singlesampling<br>plan GI, the sample to be drawn<br>isunder code M equivalent to<br>315 pieces with accept 10 and<br>reject 11 to be accepted under<br>AQL 1.5.<br>For Size XS, during the test,<br>4piece was found with leaks.<br>Hence it falls within the<br>acceptance criteria.<br>For Size S. during the test,<br>2piece was found with leaks.<br>Hence it falls within the<br>acceptance criteria.<br>For Size M, during the test,<br>3piece was found with leaks.<br>Hence it falls within the<br>acceptance criteria.<br>For Size L, during the test,<br>1piece was found<br>with leaks. Hence it falls<br>within the acceptance<br>criteria.<br>For Size XL, during the<br>test, 2piece was found<br>with leaks. Hence it falls<br>within the acceptance<br>criteria. | Pass |

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| Test<br>Method | Standard | Purpose of<br>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<br>Requirement : <2mg/glove | Sample size : 5 pcs<br>Result XS : 0.30mg/glove<br>Result S : 0.26mg/glove<br>Result M : 0.34mg/glove<br>Result L : 0.38mg/glove<br>Result XL : 0.40mg/glove | Pass |

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#### 8.0 Non-clinical performance testing methods full titles:

Non-Clinical Testing was conducted to demonstrate that the proposed device met all required design specifications. The test results demonstrated that the proposed device met the performance criteria as specified utilizing the following test methods, standards, and specifications:

- ASTM D6319-10 Standard D6319-10 Standard Specification for Nitrile Examination Gloves o for Medical Application
- ASTM D412-2006a (Reapproved 2013) Standard Test Method for Vulcanized Rubber and O Thermoplastic Elastomers-Tension
- ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an o Air Oven
- ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions O
- ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of holes in o Medical Gloves
- O ASTM D6124-2006 (Reapproved 2015) Standard Tested Method for Residual Powder on Medical Gloves
- ISO 2859 Sampling Procedures and Tables for Inspection by Attributes O
- ISO 10993-10 Biological Evaluation of medical Devices-Part 10: Tests for Irritation and o Sensitization
- ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity ೧

#### 9.0 Summary of Clinical Testing:

No clinical studies were conducted for either the subject or predict glove.

# 10.0 Differences:

There are no significant differences between the current glove and the predicate. They are identical in terms of their intended use, base materials, design, color, and manufacturing process.

# Conclusion

The conclusion drawn from the non-clinical tests demonstrate that the subject device, "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 device K192333.