K Number

Device Name

Best Glove-Latex Powder Free Examination Glove

Manufacturer

Bestsafe Glove CO., LTD.

Date Cleared

2021-11-05

(280 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

A powder-free 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

Device Description

Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578 - 19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color is added) 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

K110250

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a standard examination glove and the summary focuses on physical properties and biocompatibility testing, with no mention of AI or ML.

Therapeutic

No
The device is a patient examination glove, intended to prevent contamination, not to treat or cure a disease or condition.

Diagnostic

The device is a patient examination glove, intended to prevent contamination between the patient and examiner, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

The device description and performance studies clearly indicate a physical product (gloves) and do not mention any software components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device 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." This describes a barrier device for infection control, not a device used to examine specimens from the human body.
Device Description: The description focuses on the physical properties and materials of the glove, not on any diagnostic function.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Mentions of assays, reagents, or analytical methods
Performance Studies: The performance studies focus on the physical integrity, safety, and biocompatibility of the glove (dimensions, thickness, strength, watertightness, powder content, protein content, skin irritation, cytotoxicity, systemic toxicity). These are relevant for a medical device worn on the body, but not for an IVD.
Key Metrics: The metrics provided are related to the physical and biological properties of the glove, not diagnostic performance metrics like sensitivity, specificity, or AUC.

In summary, this device is a medical device used for barrier protection, not a device used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A powder-free 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

Product codes

LYY

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner's

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)

The performance test data of the non-clinical tests meet following standards:
ASTM D 3578 – 19 Standard Specification for Rubber Examination Gloves
ASTM D 5151-19: Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
ASTM D5712 - 15, Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber.

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

Dimensional Testing

Length: Min 230 mm for all sizes. Results: Small: 240 mm, Medium: 240 mm, Large: 240 mm, Extra Large: 241 mm (Pass)
Width: Small: 80 ± 10 mm, Medium: 95±10mm, Large: 111± 10 mm, Extra Large: 120 ± 10 mm. Results: Small: 85 mm, Medium: 93 mm, Large: 105 mm, Extra Large: 115 mm (Pass)
Thickness: Palm 0.08 mm min, Finger 0.08 mm min for all sizes. Results: Small: Palm 0.09 mm, Finger: 0.12 mm; Medium: Palm: 0.09 mm, Finger: 0.12 mm; Large: Palm 0.10 mm, Finger: 0.13 mm; Extra Large: Palm 0.09 mm, Finger: 0.12 mm (Pass)

Physical Properties

Tensile strength: Before Ageing 18Mpa Minimal, After Ageing 14Mpa Minimal.
- Before Ageing Results: Small: 18.04 MPa, Medium: 19.13 MPa, Large: 18.26 MPa, Extra Large: 18.64 MPa (Pass)
- After ageing Results: Small: 15.02 MPa, Medium: 18.12 MPa, Large: 16.01 MPa, Extra Large: 15.06 MPa (Pass)
Ultimate Elongation: Before Ageing 650% Min, After Ageing 500% Min.
- Before Ageing Results: Small: 651%, Medium: 654 %, Large:650%, Extra Large:650% (Pass)
- After ageing Results: Small:501%, Medium: 601%, Large:501%, Extra Large:502% (Pass)

Watertight test

Acceptance Criteria: Sample size: 200 pcs, Inspection level : Gl, AQL 1.5, Acceptance Number 7, Rejection Number 8.
Results: Small: 0 (Zero), Medium: 0 (Zero), Large:0 (Zero), Extra Large:0 (Zero) (Pass)

Residual powder

Acceptance Criteria: 2 mg per glove or less.
Results: Sample size : 5 pcs, Small:0.62 mg/glove, Medium: 0.46 mg/glove, Large: 0.61 mg/glove, Extra Large:0.61 mg/glove (Pass)

Protein content

Acceptance Criteria: Less than 200 µg/dm².
Results: Sample size : 3 pcs, Small:124.36 ug /dm2, Medium: 140.78 µg /dm², Large: 134.26 µg /dm², Extra 159.46 µg /dm² (Pass)

Predicate Device(s)

K110250

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 shows 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 5, 2021

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

Re: K210253

Trade/Device Name: Best Glove-Latex Powder Free Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LYY Dated: May 25, 2021 Received: August 30, 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 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 Quality Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K210253

Device Name

BEST GLOVE -LATEX POWDER FREE EXAMINATION GLOVE

Indications for Use (Describe)

A powder-free 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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRA Staff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

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 company name "BESTSAFE GLOVE CO., LTD" in smaller blue letters. There is a registered trademark symbol in the upper right corner of the logo.

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 EMAIL : SALES@BESTSAFE.CO.TH WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM

510(k) SUMMARY K210253 Latex Powder Free Examination Glove

1.0 Applicant Information

	Applicant:	BESTSAFE GLOVE CO., LTD
	Address	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
	Contact Number:	+66 81 4022099
	Contact Email:	sales@bestsafe.co.th
	Preparation date:	September 6, 2021
2.0	Device Identification:
	Trade/Proprietary Name(s):	BEST GLOVE -LATEX POWDER FREE EXAMINATION GLOVE
	Common Name:	Latex Powder Free Examination Gloves
	Classification Name:	Patient Examination Gloves
	510(k):	K210253
	Device Class:	I
	Product Code:	LYY
	Registration Number	21 CFR 880.6250
	Review Panel	General Hospital
3.0	Predicate Device
	Device Name:	MPXX™ Powder Free Natural Rubber Latex Examination Gloves
	Manufacturer:	Total Glove Company Sdn. Bhd.
	510(k):	K110250
	Device Class:	I
	Product Code:	LYY

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 side, followed by the word "BESTSAFE" in blue with a plus sign in the middle. Below "BESTSAFE" is the text "BESTSAFE GLOVE CO., LTD" in a smaller font size. There is a registered trademark symbol in the upper right corner of the logo.

52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, AMUANG, 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 EMAIL : SALES@BESTSAFE.CO.TH WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM

4.0 Description of the Device:

5.0 Indication for Use of the Device:

A powder-free 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 Technological characteristics between predicate and subject devices

Characteristics	References/Standards	Device performance		Comparison
		Predicate	Current
510(k) Number	-	K110250	K210253	---
Manufacturer(s)	-	Total Glove Company Sdn.
Bhd.	BESTSAFE GLOVE CO.,
LTD	---
Name of device	-	MPXX TM Powder Free Natural
Rubber Latex Examination
Gloves	BEST GLOVE -LATEX
POWDER FREE
EXAMINATION GLOVE	---
Indication for Use	Medical Gloves
Guidance Manual,
Issued on January 22,
2008	MPXX TM Powder Free Natural
Rubber Latex Examination
Gloves are single use device
intended for medical purposes
that is worn on the hand of
healthcare and similar
personnel to prevent
contamination between
healthcare and the patient.	A powder-free 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	Same
Material	ASTM D3578-19	Natural Rubber Latex	Natural Rubber Latex	Identical
Color		Natural Colo	Natural Colo	Same
Size	Medical Glove
Guidance Manual-
Labeling- Issued on
January 22, 2008	Extra Small
Small
Medium
Large
Extra Large	Small
Medium
Large
Extra Large	Different
Characteristics	References/Standards	Device performance		Comparison
Single Use	Medical Gloves
Guidance Manual -
Issued on January 22,
2008	Single use	Single use	Same
Sterile/Non-sterile	-	Non-sterile	Non-sterile	Same
Dimension	ASTM D3578-19	Length
230 mm minimum	Length
230 mm min	Similar
		Size	Actual value
		Small	240
		Medium	240
		Large	240
		Extra Large	241
		Width
Medium: 95 mm ± 10 mm
(for Medium size)		Different
		Size	Actual value
		Small	85
		Medium	93
		Large	105
		Extra Large	115
Thickness	ASTM D3578-19	Finger = 0.08 mm. min
Palm = 0.08 mm. Min	Finger = 0.08 mm. min
Palm = 0.08 mm. Min	Similar
		Size	Palm
(Actual value)	Finger
(Actual value)
		Small	0.09	0.12
		Medium	0.09	0.12
		Large	0.10	0.13
		Extra Large	0.09	0.12

Image /page/5/Picture/0 description: The image shows the logo for BESTSAFE. On the left is a blue hand. To the right of the hand is the word "BESTSAFE" in blue, with a plus sign in the upper left corner of the word. Below the word "BESTSAFE" is the text "BESTSAFE GLOVE CO.,LTD" in a smaller font.

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

Image /page/6/Picture/0 description: The image shows the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side. To the right of the hand is the word "BESTSAFE" in blue, with a plus sign incorporated into the "B". Below "BESTSAFE" is the text "BESTSAFE GLOVE CO.,LTD" also in blue.

Characteristics	References/Standards	Device performance		Comparison
		Predicate	Current
Physical Properties	ASTM D3578-19	Before Aging
Tensile Strength
18 MPa min
After Aging
Tensile Strength
14 MPa min	Before Aging
Tensile Strength (18 MPa min) Size Actual value Small 18.04 Medium 19.13 Large 18.26 Extra Large 18.64						Similar
Characteristics	References/Standards	Device performance		Comparison
		Predicate	Current
	Water Tight Test
(1000 ml)		ASTM D5151 – 19		Pass AQL 1.5	After Aging
Tensile Strength (14 MPa min) Size Actual value Small 15.02 Medium 18.12 Large 16.01 Extra Large 15.06	Pass AQL 1.5		Same				Similar
Powder Residual	ASTM D6124-06
(Reapproved 2017)	Meet $≤$ 2.0 mg/glove	$≤$ 2.0 mg/glove	Similar
			Size Residual powder content (mg/glove) Small 0.62 Medium 0.46 Large 0.61 Extra Large 0.61
		Before Aging
Ultimate Elongation
650% min
After Aging
Ultimate Elongation
500% min (after aging)	Before Aging
Ultimate Elongation : 650% min Size Actual value Small 651 Medium 654 Large 650 Extra Large 650						Similar
Biocompatibility	Primary Skin Irritation -
ISO 10993-10 Third
Edition 2010-08-01	Not a primary skin irritant under the conditions of the study	Not a primary skin irritant under the conditions of the study	Same
	Dermal Sensitization -
ISO 10993-10 Third
Edition 2010-08-01	Not a contact sensitizer under the conditions of the study	Not a contact sensitizer under the conditions of the study	Same
	In vitro cytotoxicity
ISO10993-5 :2009(E)	No data is available	Under the conditions of the study cytotoxic for undiluted (neat) and 1:2 dilutions but noncytotoxic for 1:4, 1:8, 1:16 and 1:32 dilutions. Moreover, under the conditions of the study, non acute systemic toxic.	Different
	Acute Systemic Toxicity
ISO10993-11:2017(E)	No data is available	Under the conditions of the study, did not induce any systemic toxicity.	Different
			After Aging
Ultimate Elongation : 500% min Size Actual value Small 501 Medium 601 Large 501 Extra Large 502						Similar

Image /page/7/Picture/0 description: The image contains 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 white cross in the middle of the "B". Below "BESTSAFE" is the text "BESTSAFE GLOVE CO., LTD" in a smaller font size. There is a registered trademark symbol in the upper right corner of the logo.

WEBSITE : WWW.BESTSAFE.CO.TH I 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 "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.

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

7.0 Summary of Non-clinical performance Tests

Test Method	Standard	Purpose of testing
Dimension	ASTM D3578-19
Standard Specification for Rubber
Examination Gloves	To determine the length
of the gloves	Min 230 mm for all sizes	Small: 240 mm
Medium: 240 mm
Large: 240 mm
Extra Large: 241 mm	Pass
	ASTM D3578-19
Standard Specification for Rubber
Examination Gloves	To determine the width
of the gloves	Small: 80 ± 10 mm
Medium: 95±10mm
Large: 111± 10 mm
Extra Large: 120 ± 10 mm	Small: 85 mm
Medium: 93 mm
Large: 105 mm
Extra Large: 115 mm	Pass
	ASTM D3578-19
Standard Specification for Rubber
Examination Gloves	To determine the
thickness of the gloves	Palm 0.08 mm min
Finger 0.08 mm min for all sizes	Small: Palm 0.09 mm, Finger: 0.12 mm
Medium: Palm: 0.09 mm, Finger: 0.12 mm
Large: Palm 0.10 mm, Finger: 0.13 mm
Extra Large: Palm 0.09 mm, Finger: 0.12 mm	Pass
Physical
Properties	ASTM D3578-19
Standard Specification for Rubber
Examination Gloves	To Determine the
physical properties-
Tensile strength	Before Ageing
Tensile Strength 18Mpa
Minimal for all sizes
After Ageing Tensile
Strength 14Mpa
Minimal for all sizes	Before Ageing
Small: 18.04 MPa
Medium: 19.13 MPa
Large: 18.26 MPa
Extra Large: 18.64 MPa
After ageing:
Small: 15.02 MPa
Medium: 18.12 MPa
Large: 16.01 MPa
Extra Large: 15.06 MPa	Pass

Image /page/9/Picture/0 description: The image contains the logo for BESTSAFE GLOVE CO., LTD. The logo features a blue hand on the left side, followed by the word "BESTSAFE" in large, bold, blue letters. Below "BESTSAFE" is the text "BESTSAFE GLOVE CO.,LTD" in smaller, blue letters. There is a registered trademark symbol in the upper right corner of the logo.

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

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 TAX ID:0215563006105

WEBSITE : WWW.BESTSAFE.CO.TH | WWW.BESTSAFEGLOVE.COM EMAIL : SALES@BESTSAFE.CO.TH

Test Method	Standard	Purpose of testing
Physical
Properties	ASTM D3578-19
Standard Specification for Rubber
Examination Gloves	To Determine the
physical properties-
Ultimate Elongation	Before Ageing
Ultimate Elongation
650% Min for all sizes
After Ageing Ultimate
Elongation 500% Min
for all sizes	Before Ageing
Small: 651%
Medium: 654 %
Large:650%
Extra Large:650%
After ageing:
Small:501%
Medium: 601%
Large:501%
Extra Large:502%	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 : Gl
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
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:0.62 mg/glove
Medium: 0.46 mg/glove
Large: 0.61 mg/glove
Extra Large:0.61 mg/glove	Pass

Image /page/10/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" in a smaller font, also in blue. There is a registered trademark symbol in the upper right corner of the logo.

52/43 WATKODHIN-KAOPHAI RD. T.TUBMA, AMUANG, 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 EMAIL : SALES@BESTSAFE.CO.TH WEBSITE : WWW.BESTSAFE.CO.TH I WWW.BESTSAFEGLOVE.COM

Status Test Method Standard Acceptance Criteria Purpose of testing Result Protein content ASTM D5712 - 15, Standard Test Less than 200 µg/dm² Pass To determine the Sample size : 3 pcs extractable protein in Method for Analysis of Aqueous Requirement: Less than 200 µg/dm2 Extractable Protein in Natural the gloves Result Small:124.36 ug /dm2 Rubber. Medium: 140.78 µg /dm² Large: 134.26 µg /dm² Extra 159.46 µg /dm²

The performance test data of the non-clinical tests meet following standards:

ASTM D 3578 – 19 Standard Specification for Rubber Examination Gloves

ASTM D 5151-19: Standard Test Method for Detection of Holes in Medical Gloves

ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves

ASTM D5712 - 15, Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber.

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8.0 Summary of Clinical Performance Tests:

Not Applicable

9.0 Conclusion:

The conclusion drawn from the non-clinical tests demonstrates that the subject device Latex Examination Powder Free Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device K110250

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