This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

Class I latex patient examination glove 80LZA, powder free and meeting all the requirements of ASTM-D3578-61) Standard Specification for Latex Examination Gloves for Medical Application, except for the elongation at break parameter.

AI/ML Overview

This document describes the acceptance criteria and performance of the "POWDER-FREE, 'BARRIER-PRO™, SYNTHETIC BUTADIENE CO-POLYMER EXAM GLOVES, COLOR: GREEN" manufactured by Shield Gloves, as submitted for 510(k) clearance (K011613).

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (ASTM D3578-00/99)	Reported Device Performance (Shield Gloves)
Dimension
X-Small Width	70 mm +/- 10 mm	70 - 75 mm
Small Width	80 mm +/- 10 mm	80 - 85 mm
Medium Width	95 mm +/- 10 mm	90 - 97 mm
Large Width	111 mm +/- 10 mm	105 - 111 mm
Length (all sizes)	230 mm minimum	242 mm
Finger Thickness	0.08 mm minimum	0.08 mm minimum
Palm Thickness	0.08 mm minimum	0.08 mm minimum
Tensile Strength (Mpa)
Before Aging	14.0	X-Small: 25.3, Small: 26.0, Medium: 28.9, Large: 22.0
After Aging	14.0	X-Small: 21.3, Small: 23.4, Medium: 23.6, Large: 21.7
Ultimate Elongation (%)
Before Aging	700	X-Small: 840, Small: 850, Medium: 860, Large: 840
After Aging	500	X-Small: 890, Small: 930, Medium: 940, Large: 900
Water Tight Test (Leakage)	2.5% AQL (Acceptance Quality Limit)	Un-aged: X-Small (2/125), Small (0/125), Medium (1/125), Large (0/125)Aged: X-Small (1/125), Small (2/125), Medium (1/125), Large (0/125) (All within 2.5% AQL)
Biocompatibility	Non-dermal irritant, non-skin sensitizer	Neither a dermal irritant nor a skin sensitizer
Residual Powder Content (ASTM D 6124-00)	2 mg/glove max	Range: 0.7-1.5 mg/glove, Mean: 1.05 mg/glove
Presence of Cornstarch	Negative	Negative

Note: The device explicitly states that it meets/exceeds ASTM-D3578 Standard Specifications for Latex Examination Gloves, except for the elongation at break parameter. However, the provided tables show that the "Ultimate Elongation" for the Shield Gloves exceeds the ASTM-D3578-00 requirement for both before and after aging. This might be a misunderstanding of the "elongation at break parameter" or an older ASTM standard being referenced in the summary text. Based on the provided table, the performance for Ultimate Elongation is better than the ASTM standard.

2. Sample Sizes Used for the Test Set and Data Provenance

Water Tight Test: 125 pieces per size (X-Small, Small, Medium, Large) for both un-aged and aged gloves. This totals 1000 gloves tested specifically for the water leak test (4 sizes * 125 gloves/size * 2 aging conditions).
Tensile Strength & Ultimate Elongation: The data is reported for each size (X-Small, Small, Medium, Large) for both before and after aging. The specific number of samples tested for these mechanical properties is not explicitly stated, but it is reported for "Lot# 1128".
Residual Powder Content: The range (0.7-1.5mg/glove) and mean (1.05 mg/glove) suggest multiple samples were tested, but the total sample size is not specified.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Shield Gloves Manufacturing (M) Sdn Bhd is the applicant and is located in Malaysia (implied by "Sdn. Bhd." and context), it is highly likely the testing was conducted by or for the manufacturer, presumably in Malaysia, as part of their product development and regulatory submission. The testing would be considered prospective for the purpose of this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a medical glove, and its performance is evaluated against engineering and material standards (e.g., ASTM D3578) and regulatory requirements (e.g., FDA water leak test, biocompatibility, powder content). Ground truth is established by these objective standards and tests, not by expert interpretation of clinical images or subjective assessments typically requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., in clinical trials or image interpretation) where multiple experts might disagree on an outcome. For objective physical and chemical tests of a medical glove, the results are typically quantitative measurements or pass/fail criteria based on defined standards, not requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a physical medical glove and does not involve AI or human "readers" in its intended use or evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical glove and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for most of the performance criteria is based on established industry standards and regulatory requirements:

ASTM-D3578-00/99: "Standard Specification for Latex Examination Gloves for Medical Application" (for Dimension, Tensile Strength, Ultimate Elongation).
FDA specified water leak test: A specific methodology for determining watertight integrity.
Biocompatibility standards: Tests for dermal irritation and skin sensitization.
ASTM D 6124-00: For Residual Powder Content.
FDA claim criterion: For a powder-free glove (presence of cornstarch).

These standards define the objective and measurable criteria for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical glove, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process of physical goods involves quality control and process validation, which might use statistical sampling (e.g., during production runs) but is distinct from an AI training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this physical device.

Summary

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SEP 1 7 2001

APPENDIX K

510(k) SUMMARY

SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWIDER-FREE, "BARRIER-PROw", SYNTHETIC BUTADIENE CO-POLYMER EXAM GLOVES, COLOR: GREEN

KO11613

Contact person : Ong Lay Mau

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Device Information:

Trade Name - See above complete title for this exam glove.

Common Name - Exam gloves

Classification Name - Patient examination glove (per 21 CFR 880 6250)

Classification Information - Class I latex patient examination glove 80LZA powder free and meeting all the requirements of ASTM-D3578-01 Standard Specification for Latex Examination Gloves for Medical Application ( except for the elongation at break parameter.

Device Description:

Intended Use of Device:

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Technological Characteristics of Device.

1. Dimension

DIMENSION	ASTM D3578-99	Shield Gloves
X-Small	70 mm +/- 10 mm	70 - 75 mm
Small	80 mm +/- 10mm	80 - 85 mm
Medium	95 mm +/- 10mm	90 - 97 mm
Large	111mm +/- 10mm	105-111 mm
Length	230 mm minimumfor all sizes	242mm
Thickness -FingerPalm	0.08mm min0.08mm min	0.08 mm min0.08 mm min

(Revised 8-9-01)
(Revised 9-10-01)

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	TENSILE STRENGTH		ULTIMATE ELONGATION
	ASTM-D3578-00	SGMP	ASTM-D3578-00	SGMP
	Mpa	Mpa	%	%
Before Aging	14.0		700
X-Small		25.3		840
Small		26.0		850
Medium		28.9		860
Large		22.0		840
After Aging	14.0		500
X-Small		21.3		890
Small		23.4		930
Medium		23.6		940
Large		21.7		900

1. Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) on Lot# 1128

3. Water Tight Test

Using the FDA specified 1,000 ml water leak test, 125 pieces of each size of the gloves were tested and our results are as given below:

BATCH #1128	SIZE	SAMPLE SIZE	LEAK STATUS	NUMBERLEAKED
UN-AGED
	X-Small	125	Yes	2
	Small	125	No	0
	Medium	125	Yes	1
	Large	125	No	0
AGED
	X-Small	125	Yes	1
	Small	125	Yes	2
	Medium	125	Yes	1
	Large	125	No	0

The above figures are within the gloves of 2.5% AQL.

. FDA/ASTM D3578-00 requirements for latex exam

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Biocompatibility ﻧ

The bio-compatibility test results show that the glove is neither a dermal irritant nor a skin sensitizer.

5. Total Residual Powder Content & Presence of Cornstarch

TESTSREQUIREMENT	FDA	Shield's
Residual PowderContent(ASTM D 6124-00)	2 mg/glove max	Range: 0.7-1.5mg/gloveMean : 1.05 mg/glove
Presence of Cornstarch	Negative	Negative

Conclusion :-

The data presented indicate that this Synthetic Butadiene Co-Polymer glove.

meets/exceeds ASTM- D3578 Standard Specifications For Latex Examination Glove, except for 1. the elongation at break parameter,
meets FDA pinhole requirements, ಗಳ
meets FDA claim criterion of a powder free glove, ਡ

510(K) Summary Page 3 of 3

Revised 8-9-01)
Revised 9-10-01)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines representing its wings or body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2001

Shield Gloves Manufacturing (M) Sdn Bhd C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550

Re: K011613

Trade/Device Name: Powder-Free Green "Barrier-Pro™" Synthetic Butadiene Copolymer Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: July 9, 2001 Received: July 13, 2001

Dear Ms. Tucker:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Tucker

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal states and squirements, including, but not limited to: registration 1 ou must comply with and are rabeling (21 CFR Part 801); good manufacturing practice and ilsung (21 OF R Part 807), as ality systems (QS) regulation (21 CFR Part 820); and if requirences as betronic product radiation control provisions (section 531-542 of the Act; 21): CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 510(k) I mis letter will and in the FDA finding of substantial equivalence of your device to a premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Timothy A. Ulstanski

Timoth A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE STATEMENT

Applicant: Shield Gloves Manufacturer (M) Sdn. Bhd.

Koll613 510K Number:

Device Name: NON-STERILE, POWDER-FREE, "BARREER-PROTH" SYRTHETIC NON-STERILE, POWDER-FREE, "BARIOVES, COLOR: GREEN

Indications for Use :

This is a medical glove to be worn on the hand of health care and similar personnel to prevent
. contamination between health care personnel and the patient.

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use ... Per 21 CFR 801.109 OR

Over-The-Counter ...

(Revised 9-10-01)

²
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Device 10(k) Number

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.