Best Glove-Nitrile Powder Free Examination Glove

K210249 · Bestsafe Glove Co., Ltd. · LZA · Oct 25, 2021 · General Hospital

Device Facts

• Record ID: K210249
• Device Name: Best Glove-Nitrile Powder Free Examination Glove
• Applicant: Bestsafe Glove Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Best Glove - Nitrile Powder Free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination glove; worn on examiner's hand; prevents cross-contamination between patient and examiner. Manufactured from acrylonitrile-butadiene copolymer; blue color; powder-free; finger-textured. Used in clinical settings by healthcare professionals. Provides physical barrier protection. Benefits patient and examiner by reducing risk of infection transmission during medical examinations.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via ASTM standards for dimensions, physical properties (tensile strength, elongation), watertightness (ASTM D5151-19), residual powder (ASTM D6124-06), and biocompatibility (ISO 10993-5, 10, 11).

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (Nitrile). Standards: ASTM D6319-19 (dimensions, physical properties), ASTM D5151-19 (watertightness), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-5, 10, 11. Form factor: Finger-textured, blue, powder-free, disposable. Non-sterile.

Indications for Use

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

• Palm Care Blue Nitrile Examination Gloves Powder Free (K202384)

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.

October 25, 2021

Bestsafe Glove CO., LTD Piyawat Chirasakulkarun Chief Executive Officer 52/43 Wat Khot Hin-Khao Phai Road, Tubma Muang Rayong, Rayong 21000 Thailand

Re: K210249

Trade/Device Name: Best Glove-Nitrile Powder Free Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 30, 2021 Received: September 24, 2021

Dear Piyawat Chirasakulkarun:

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

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

Sincerely,

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 Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K210249

Device Name BEST GLOVE -NITRILE POWDER FREE EXAMINATION GLOVE

Indications for Use (Describe)

Best Glove - Nitrile Powder Free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand 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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Image /page/3/Picture/0 description: The image shows the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side, followed by the word "BESTSAFE" in blue, with a plus sign in the middle of the word. Below the word "BESTSAFE" is the text "BESTSAFE GLOVE CO., LTD" in a smaller font size, also in blue. There is a registered trademark symbol in the upper right corner of the logo.

### BESTSAFE GLOVE CO.,LTD. I บริษัท เบสท์เซฟ

52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, A.MUANG, RAYONG, RAYONG. THAILAND 21000 TEL OFFICE : 038-949877-79 FAX : [phone] TAX ID : 0215563006105 TEL H/P : [phone] , [phone] ,[phone] WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM EMAIL : [e-mail]

## 510(k) SUMMARY K210249 Nitrile Powder Free Examination Gloves

### 1.0 Submitter:

| Applicant: | BESTSAFE GLOVE CO., LTD<br>52/43 Watkodhin-Kaophai Rd. T.Tubma, | |
|-------------------------|-----------------------------------------------------------------|--|
| | A.Muang Rayong Rayong. THAILAND 21000 | |
| Phone Number: | [phone] | |
| Fax Number: | [phone] | |
| Name of Contact Person: | Piyawat Chirasakulkarun | |
| Preparation date: | July 30, 2021 | |

#### 2.0 Identification of the subjected device:

| Trade/Proprietary Name(s): | BEST GLOVE -NITRILE POWDER FREE EXAMINATION GLOVE |
|----------------------------|---------------------------------------------------|
| Common Name: | Nitrile Powder Free Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Classification: | I |
| Product code | LZA |
| Regulation Number: | 21 CFR 880.6250 |

#### 3.0 Predicate Device:

| Device Name: | Palm Care Blue Nitrile Examination Gloves Powder Free |
|------------------------|-------------------------------------------------------|
| 510(k): | K202384 |
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Classification: | I |
| Product Code: | LZA |
| Regulation Number: | 21 CFR 880.6250 |

#### 4.0 Description of the Device:

Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.

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Image /page/4/Picture/0 description: The image shows the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left, followed by the word "BESTSAFE" in blue, with a plus sign in the middle of the word. Below "BESTSAFE" is the text "BESTSAFE GLOVE CO., LTD" also in blue. There is a registered trademark symbol in the upper right corner of the logo.

#### 5.0 Indication for Use:

Best Glove Nitrile Powder Free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

#### 6.0 Summary of Technological Characteristics of the Device Compared to the Predicate Device:

| Characteristics | Standards | Device performance | | Comparison |
|------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | Predicate | Current | |
| 510(k) Number | - | K202384 | K210249 | ---- |
| Manufacturer(s) | - | Hi-Care Thai Gloves Co.<br>Ltd | BESTSAFE GLOVE CO.,<br>LTD | ---- |
| Indication for Use | Medical Gloves<br>Guidance Manual -<br>Issued on January<br>22, 2008 | A powder-free patient Examination Gloves 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 | Best Glove Nitrile Powder Free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | Similar |
| Material | ASTM D6319-19 | Nitrile (NBR) | Nitrile (NBR) | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Textured | Finger Textured | Same |
| Size | ASTM D6319-19 | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Small<br>Medium<br>Large<br>Extra Large | Different |
| Single Use | Medical Gloves<br>Guidance Manual -<br>Issued on January<br>22, 2008 | Single use | Single use | Same |
| Dimension | ASTM D6319-19 | Length 230 mm min.<br>Width 95 ± 10 mm min<br>(for Medium size) | Length 230 mm min<br>Width 95 ± 10 mm min<br>(for Medium size) | Same |
| | Standards | Device performance | | |
| Characteristics | | Predicate | Current | Comparison |
| Thickness | ASTM D6319-19 | Finger: 0.05 mm min<br>Palm: 0.05 mm min | Finger: 0.05 mm min<br>Palm: 0.05 mm min | Same |
| Physical<br>Properties | ASTM D6319-19 | <b>Before aging</b><br>Tensile Strength:<br>14 MPa min<br>Ultimate Elongation:<br>500% min<br><b>After aging</b><br>Tensile Strength<br>14 MPa min<br>Ultimate Elongation:<br>400% min | <b>Before aging</b><br>Tensile Strength:<br>14 MPa min<br>Ultimate Elongation:<br>500% min<br><b>After aging</b><br>Tensile Strength<br>14 MPa min<br>Ultimate Elongation:<br>400% min | Same |
| Watertight test<br>(1000 ml) | ASTM D5151-19 | Pass AQL 1.5 | Pass AQL 1.5 | Similar |
| Powder Residue | ASTM D6124-06<br>(Reapproved 2017) | ≤ 2.0 mg/glove | ≤ 2.0 mg/glove | Similar |
| Biocompatibility | Primary Skin<br>Irritation -<br>ISO 10993-10 Third<br>Edition 2010-08-01 | Under the conditions<br>of the study, not an<br>irritant | Under the conditions<br>of the study, not an<br>irritant | Same |
| | Dermal<br>Sensitization -<br>ISO 10993-10 Third<br>Edition 2010-08-01 | Under the conditions<br>of the study, not a<br>sensitizer | Under the conditions<br>of the study, not a<br>sensitizer | Same |
| | In vitro cytotoxicity<br>ISO10993-5<br>:2009(E) | Under the conditions<br>of the study, noncytotoxic | Under the conditions of the<br>study cytotoxic for<br>undiluted (neat) and 1:2<br>dilutions but noncytotoxic<br>for 1:4, 1:8 and 1:16<br>dilutions. Moreover, under<br>the conditions of the study,<br>did not induce any<br>systemic toxicity. | Similar |
| | Acute Systemic<br>Toxicity ISO10993-<br>11:2017(E) | Under the conditions of<br>study, the device extracts do<br>not pose a systemic toxicity | Under the conditions of the<br>study, did not induce any<br>systemic toxicity. | Same |

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Image /page/5/Picture/0 description: The image shows the logo for BESTSAFE. The logo consists of a blue hand on the left side, followed by the word "BESTSAFE" in blue, with a plus sign in the middle of the word. Below the word "BESTSAFE" is the text "BESTSAFE GLOVE CO.,LTD" in a smaller font size.

# BESTSAFE GLOVE CO.,LTD. | บริษัท เบสท์เซฟ โกลฟ

52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, A.MUANG, RAYONG, RAYONG. THAILAND 21000

TAX ID : 0215563006105 TEL OFFICE : 038-949877-79 FAX : [phone] TEL H/P : [phone] , [phone] ,[phone] WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM EMAIL : [e-mail]

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standards.

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Image /page/6/Picture/0 description: The image contains the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side and the word "BESTSAFE" in blue with a plus sign in the middle. Below "BESTSAFE" is the text "BESTSAFE GLOVE CO., LTD" also in blue.

## BESTSAFE GLOVE CO.,LTD. | บริษัท เบสท์เซฟ โกลฟ จำกัด

52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, A.MUANG, RAYONG, RAYONG. THAILAND 21000

TAX ID : 0215563006105 TEL OFFICE : 038-949877-79 FAX : [phone] TEL H/P : [phone] , [phone] ,[phone] WEBSITE : WWW.BESTSAFE.CO.TH | WWW.BESTSAFEGLOVE.COM EMAIL : [e-mail]

#### Non-clinical testing summary 7.0

Performance Data

| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
|------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Dimension | ASTM D6319-19<br>Standard Specification for Nitrile<br>Examination Gloves for Medical<br>Application | To determine the length<br>of the gloves | Min 230 mm for all sizes | Small: 243 mm<br>Medium: 240 mm<br>Large: 240 mm<br>Extra Large: 240 mm | Pass |
| | ASTM D6319-19<br>Standard Specification for Nitrile<br>Examination Gloves for Medical<br>Application | To determine the width<br>of the gloves | Small: $80 \pm 10$ mm<br>Medium: $95 \pm 10$ mm<br>Large: $110 \pm 10$ mm<br>Extra Large: $120 \pm 10$ mm | Small: 85 mm<br>Medium: 93 mm<br>Large: 105 mm<br>Extra Large: 115 mm | Pass |
| | ASTM D6319-19<br>Standard Specification for Nitrile<br>Examination Gloves for Medical<br>Application | To determine the<br>thickness of the gloves | Palm 0.05 mm min<br>Finger 0.05 mm min for all sizes | Small: Palm 0.09 mm, Finger: 0.13 mm<br>Medium: Palm: 0.06 mm, Finger: 0.08 mm<br>Large: Palm 0.09 mm, Finger: 0.12 mm<br>Extra Large: Palm 0.09 mm, Finger: 0.12 mm | Pass |
| Watertight test | ASTM D5151-19<br>Standard Test Method for Detection<br>of Holes in Medical<br>Gloves | To determine the holes in<br>the gloves | Sample size: 200 pcs<br>Inspection level : GI<br>AQL 1.5<br>Acceptance Number 7<br>Rejection Number 8 | The batch size for this sampling is 35,001-<br>150,000. Hence, according to the single<br>sampling plan GI, the sample to be drawn is<br>under code L equivalent to 200 pcs with<br>accept 7 and reject 8 to be accept under<br>AQL 1.5<br>Small: 0 (Zero)<br>Medium: 0 (Zero)<br>Large:0 (Zero)<br>Extra Large:0 (Zero). | Pass |
| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
| Residual<br>powder | ASTM D6124-06 (Reapproved 2017)<br>Standard Test Method for Residual<br>Powder on Medical Gloves | To determine the residual<br>powder in the gloves | 2 mg per glove or less | Sample size : 5 pcs<br>Requirement: 2 mg per glove or less<br>Result<br>Small:1.42 mg/glove<br>Medium: 0.50 mg/glove<br>Large: 1.34 mg/glove<br>Extra Large:1.36 mg/glove | Pass |
| Physical<br>Properties | ASTM D6319-19<br>Standard Specification for Nitrile<br>Examination Gloves for Medical<br>Application | To Determine the<br>physical properties-<br>Tensile strength | Before Ageing<br>Tensile Strength 14Mpa<br>Minimal for all sizes<br>After Ageing Tensile<br>Strength 14Mpa<br>Minimal for all sizes | Before Ageing<br>Small: 18.37 MPa<br>Medium: 30.62 MPa<br>Large: 18.30 MPa<br>Extra Large: 18.20 MPa<br>After ageing:<br>Small: 14.08 MPa<br>Medium: 31.89 MPa<br>Large: 14.00 MPa<br>Extra Large: 14.00 MPa | Pass |
| | | To Determine the<br>physical properties-<br>Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>500% Min for all sizes<br>After Ageing Ultimate<br>Elongation 400% Min<br>for all sizes | Before Ageing:<br>Small: 612%<br>Medium: 500 %<br>Large:620%<br>Extra Large:587%<br>After ageing:<br>Small:408%<br>Medium: 499%<br>Large:403%<br>Extra Large:416% | Pass |

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Image /page/7/Picture/0 description: The image shows the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side, followed by the word "BESTSAFE" in blue capital letters with a plus sign in the middle of the B. Below "BESTSAFE" is the text "BESTSAFE GLOVE CO., LTD" in smaller blue capital letters. There is a registered trademark symbol in the upper right corner of the logo.

# BESTSAFE GLOVE CO.,LTD. | บริษัท เบสท์เซฟ โกลฟ จำกัด

52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, A.MUANG, RAYONG, RAYONG. THAILAND 21000

TAX ID : 0215563006105 TEL OFFICE : 038-949877-79 FAX : [phone] TEL H/P : [phone] , [phone] ,[phone] WEBSITE : WWW.BESTSAFE.CO.TH | WWW.BESTSAFEGLOVE.COM EMAIL : [e-mail]

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Image /page/8/Picture/0 description: The image shows the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side, followed by the word "BESTSAFE" in blue, with a plus sign in the middle of the word. Below the word "BESTSAFE" is the company name "BESTSAFE GLOVE CO., LTD" in blue. There is a registered trademark symbol in the upper right corner of the logo.

BESTSAFE GLOVE CO.,LTD. | บริษัท เบสท์เซฟ โ 52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, A.MUANG, RAYONG, RAYONG. THAILAND 21000 TAX ID:0215563006105 TEL OFFICE : 038-949877-79 FAX : [phone] TEL H/P : [phone] , [phone] ,[phone] WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM EMAIL : [e-mail]

#### 8.0 Clinical Testing Summary

Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

#### 9.0 Conclusion:

The conclusions drawn from the non-clinical test demonstrate that the subject device Nitrile Powder Free Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device K202384

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