K Number

Device Name

Best Glove-Nitrile Powder Free Examination Glove

Manufacturer

Bestsafe Glove CO., LTD

Date Cleared

2021-10-25

(269 days)

Product Code

LZA

Regulation Number

880.6250

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 Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K202384

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a standard examination glove and the summary contains no mention of AI or ML.

Therapeutic

No
The device is a glove intended to prevent contamination, not to provide therapy or treatment for a disease or condition.

Diagnostic

No.
The device is an examination glove, used to prevent contamination, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

The device is a physical examination glove, not a software application. The description clearly states it is a disposable device worn on the hand and made from acrylonitrile-butadiene copolymer dispersion.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is "worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The description identifies it as a "Class I patient examination glove." Examination gloves are not typically classified as IVDs.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Providing diagnostic information
- Using reagents or assays

The information provided aligns with the description of a medical device used for personal protection and preventing cross-contamination, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

LZA

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing summary 7.0 Performance Data:

Dimension:
- Length: Determines length of gloves. Acceptance criteria: Min 230 mm for all sizes. Results: Small: 243 mm, Medium: 240 mm, Large: 240 mm, Extra Large: 240 mm. Status: Pass.
- Width: Determines width of gloves. Acceptance criteria: Small: 80 ± 10 mm, Medium: 95 ± 10 mm, Large: 110 ± 10 mm, Extra Large: 120 ± 10 mm. Results: Small: 85 mm, Medium: 93 mm, Large: 105 mm, Extra Large: 115 mm. Status: Pass.
- Thickness: Determines thickness of gloves. Acceptance criteria: Palm 0.05 mm min, Finger 0.05 mm min for all sizes. Results: Small: Palm 0.09 mm, Finger: 0.13 mm; Medium: Palm: 0.06 mm, Finger: 0.08 mm; Large: Palm 0.09 mm, Finger: 0.12 mm; Extra Large: Palm 0.09 mm, Finger: 0.12 mm. Status: Pass.
Watertight test: Determines holes in gloves. Sample size: 200 pcs (under code L, for a batch size of 35,001-150,000). Acceptance criteria: Inspection level: GI, AQL 1.5, Acceptance Number 7, Rejection Number 8. Results: Small: 0 (Zero), Medium: 0 (Zero), Large: 0 (Zero), Extra Large: 0 (Zero). Status: Pass.
Residual powder: Determines residual powder in gloves. Sample size: 5 pcs. Acceptance criteria: 2 mg per glove or less. Results: Small: 1.42 mg/glove, Medium: 0.50 mg/glove, Large: 1.34 mg/glove, Extra Large: 1.36 mg/glove. Status: Pass.
Physical Properties:
- Tensile strength:
  - Before Ageing: Acceptance criteria: 14 MPa min for all sizes. Results: Small: 18.37 MPa, Medium: 30.62 MPa, Large: 18.30 MPa, Extra Large: 18.20 MPa. Status: Pass.
  - After Ageing: Acceptance criteria: 14 MPa min for all sizes. Results: Small: 14.08 MPa, Medium: 31.89 MPa, Large: 14.00 MPa, Extra Large: 14.00 MPa. Status: Pass.
- Ultimate Elongation:
  - Before Ageing: Acceptance criteria: 500% Min for all sizes. Results: Small: 612%, Medium: 500%, Large: 620%, Extra Large: 587%. Status: Pass.
  - After Ageing: Acceptance criteria: 400% Min for all sizes. Results: Small: 408%, Medium: 499%, Large: 403%, Extra Large: 416%. Status: Pass.
Biocompatibility:
- Primary Skin Irritation: Under the conditions of the study, not an irritant. Same as predicate.
- Dermal Sensitization: Under the conditions of the study, not a sensitizer. Same as predicate.
- In vitro cytotoxicity: Under the conditions of the study cytotoxic for undiluted (neat) and 1:2 dilutions but noncytotoxic for 1:4, 1:8 and 1:16 dilutions. Moreover, under the conditions of the study, did not induce any systemic toxicity. Similar to predicate.
- Acute Systemic Toxicity: Under the conditions of the study, did not induce any systemic toxicity. Same as predicate.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Watertight test: Pass AQL 1.5.
Powder Residue: ≤ 2.0 mg/glove.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K202384

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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 : (+66)038-694493, 038-949899 TAX ID : 0215563006105 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558 WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM EMAIL : SALES@BESTSAFE.CO.TH

510(k) SUMMARY K210249 Nitrile Powder Free Examination Gloves

1.0 Submitter:

| Applicant: | BESTSAFE GLOVE CO., LTD
52/43 Watkodhin-Kaophai Rd. T.Tubma, | |
|-------------------------|-----------------------------------------------------------------|--|
| | A.Muang Rayong Rayong. THAILAND 21000 | |
| Phone Number: | +66 (038)-949880 | |
| Fax Number: | +66 (038)-949850 | |
| 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:

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.
Ltd	BESTSAFE GLOVE CO.,
LTD	----
Indication for Use	Medical Gloves
Guidance Manual -
Issued on January
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
Small
Medium
Large
Extra Large	Small
Medium
Large
Extra Large	Different
Single Use	Medical Gloves
Guidance Manual -
Issued on January
22, 2008	Single use	Single use	Same
Dimension	ASTM D6319-19	Length 230 mm min.
Width 95 ± 10 mm min
(for Medium size)	Length 230 mm min
Width 95 ± 10 mm min
(for Medium size)	Same
	Standards	Device performance
Characteristics		Predicate	Current	Comparison
Thickness	ASTM D6319-19	Finger: 0.05 mm min
Palm: 0.05 mm min	Finger: 0.05 mm min
Palm: 0.05 mm min	Same
Physical
Properties	ASTM D6319-19	Before aging
Tensile Strength:
14 MPa min
Ultimate Elongation:
500% min
After aging
Tensile Strength
14 MPa min
Ultimate Elongation:
400% min	Before aging
Tensile Strength:
14 MPa min
Ultimate Elongation:
500% min
After aging
Tensile Strength
14 MPa min
Ultimate Elongation:
400% min	Same
Watertight test
(1000 ml)	ASTM D5151-19	Pass AQL 1.5	Pass AQL 1.5	Similar
Powder Residue	ASTM D6124-06
(Reapproved 2017)	≤ 2.0 mg/glove	≤ 2.0 mg/glove	Similar
Biocompatibility	Primary Skin
Irritation -
ISO 10993-10 Third
Edition 2010-08-01	Under the conditions
of the study, not an
irritant	Under the conditions
of the study, not an
irritant	Same
	Dermal
Sensitization -
ISO 10993-10 Third
Edition 2010-08-01	Under the conditions
of the study, not a
sensitizer	Under the conditions
of the study, not a
sensitizer	Same
	In vitro cytotoxicity
ISO10993-5
:2009(E)	Under the conditions
of the study, noncytotoxic	Under the conditions of the
study cytotoxic for
undiluted (neat) and 1:2
dilutions but noncytotoxic
for 1:4, 1:8 and 1:16
dilutions. Moreover, under
the conditions of the study,
did not induce any
systemic toxicity.	Similar
	Acute Systemic
Toxicity ISO10993-
11:2017(E)	Under the conditions of
study, the device extracts do
not pose a systemic toxicity	Under the conditions of the
study, did not induce any
systemic toxicity.	Same

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 : (+66)038-694493, 038-949899 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558 WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM EMAIL : SALES@BESTSAFE.CO.TH

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.

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 : (+66)038-694493, 038-949899 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558 WEBSITE : WWW.BESTSAFE.CO.TH | WWW.BESTSAFEGLOVE.COM EMAIL : SALES@BESTSAFE.CO.TH

Non-clinical testing summary 7.0

Performance Data

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

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 : (+66)038-694493, 038-949899 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558 WEBSITE : WWW.BESTSAFE.CO.TH | WWW.BESTSAFEGLOVE.COM EMAIL : SALES@BESTSAFE.CO.TH

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 : (+66)038-694493, 038-949899 TEL H/P : +66-0-86-3173770 , +66-0-81-4022099 ,+66-0-62-325-6558 WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM EMAIL : SALES@BESTSAFE.CO.TH

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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