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 Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device, SMART SHIELD™ POWDER FREE COLORED NITRILE EXAMINATION GLOVES WITH BUBBLE GUM SCENT, meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria	Reported Device Performance
Dimension
Width	Small: 80 mm +/- 10mm (ASTM D3578-95)	Small: 80 - 85 mm
	Medium: 90 mm +/- 10mm (ASTM D3578-95)	Medium: 90 - 97 mm
	Medium-Large: 100mm +/- 10mm (ASTM D3578-95)	Medium-Large: 105 - 110 mm
	Large: 111mm +/- 10mm (ASTM D3578-95)	Large: 111 - 114 mm
Length	230 mm minimum for all sizes (ASTM D3578-95)	240 mm minimum for all sizes
Thickness (Finger)	0.08 mm minimum (ASTM D3578-95)	0.08 mm minimum
Thickness (Palm)	0.08 mm minimum (ASTM D3578-95)	0.08 mm minimum
Tensile Strength (Before Aging)	14.0 MPa (ASTM D3578-95); 12.5 MPa (ASTM DRAFT NITRILE)	18.0 MPa
Tensile Strength (After Aging)	14.0 MPa (ASTM D3578-95); 12.5 MPa (ASTM DRAFT NITRILE) for 22 HRS @ 100°C	16.0 MPa
Ultimate Elongation (Before Aging)	700% (ASTM D3578-95); 500% (ASTM DRAFT NITRILE)	600%
Ultimate Elongation (After Aging)	500% (ASTM D3578-95); 400% (ASTM DRAFT NITRILE) for 22 HRS @ 100°C	500%
Water Tight Test	Meets FDA Water Leak Test Requirements (G1 single sampling plan with 1,000 ml water leak test for 200 pieces of each size, per ASTM D 5151-90)	Small: 4 leaks out of 200; Medium: 1 leak out of 200; M-Large: 2 leaks out of 200; Large: 3 leaks out of 200. (All considered to meet requirements).
Biocompatibility - Primary Dermal Irritation Test	Passes Biocompatibility Requirements	Passes
Biocompatibility - Skin Sensitization Study	Passes Biocompatibility Requirements	Passes
Residual Powder Content	Not exceeding 2 mg per glove (FDA internal requirements; measured by ASTM D 6124)	Range: 1.4-1.9 mg/glove; Mean: 1.7 mg per glove
Cornstarch Presence	Negative (Iodine Test)	Negative

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

For the water-tightness test, the sample size used was 200 pieces for each glove size (Small, Medium, M-Large, Large). This suggests a total of 800 gloves were tested for water tightness.
The data provenance is from the manufacturer's internal testing (Shield Gloves Mfr's), conducted to meet FDA and ASTM standards. The specific country of origin is Malaysia (Shield Gloves Manufacturer (M) Sdn. Bhd.). The data appears to be prospective as it involves direct testing of manufactured batches.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for any of the tests. The tests performed (dimension, physical properties, water leak, biocompatibility, residual powder) are objective measurements against established ASTM and FDA standards, not subjective expert assessments.

4. Adjudication Method for the Test Set

No adjudication method is described, as the tests rely on objective measurements and pass/fail criteria against predefined standards (ASTM, FDA). There is no indication of a need for expert adjudication for these specific performance metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of results (e.g., radiology images) to assess the impact of AI on human reader performance. For examination gloves, the performance metrics are largely objective and physical.

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

Yes, the studies described are all standalone performance evaluations of the glove itself. There is no algorithm or human-in-the-loop component relevant to the testing presented. The device is a physical product, not an AI or software-as-a-medical-device.

7. The Type of Ground Truth Used

The ground truth for all evaluated parameters were established standards and specifications:

ASTM D3578-95 and ASTM DRAFT NITRILE for dimensions, tensile strength, and ultimate elongation.
FDA specified 1,000 ml water leak test and ASTM D 5151-90 for water tightness.
FDA biocompatibility requirements for primary dermal irritation and skin sensitization.
FDA internal requirements (not exceeding 2 mg/glove) for residual powder content, measured by ASTM D 6124.
Negative Iodine test for cornstarch presence.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical product (nitrile gloves) and not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as above; there is no training set for a physical medical glove.

Summary

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K991744

APPENDIX G

510(K) SUMMARY

SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR SMART SHIELD POWDER FREE COLORED NITRILE EXAMINATION GLOVES WITH BUBBLE GUM SCENT

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	- SMART SHIELD™ POWDER FREE COLORED NITRILE
	EXAMINATION GLOVES WITH BUBBLE GUM SCENT
Common Name	- Exam gloves
Classification Name	- Patient examination glove (per 21 CFR 880.6250)
Classification Information	- Class I, 80 LZA - Nitrile patient examination glove, Powder free
	Meets all requirements of the ASTM Draft Standard Specification
	for Nitrile Examination Gloves for Medical Application.

Device Description:

Class I Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application.

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 D3578-95	ROYAL SHIELD
SmallMediumMedium-LargeLarge	80 mm +/- 10mm90 mm +/- 10mm100mm +/- 10mm111mm +/- 10mm	80 - 85 mm90 - 97 mm105 - 110 mm111 - 114 mm
Length	230 mm minimumfor all sizes	240mm min.for all sizes
Thickness -FingerPalm	0.08mm minimum0.08mm minimum	0.08 mm min.0.08 mm min.

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K991744

2. Physical Properties

TESTS	TENSILE STRENGTH			ULTIMATE ELONGATION
	ASTMD 3578-95	ASTMDRAFTNITRILE	SHIELDGLOVESMFR'S	ASTMD 3578-95	ASTMDRAFTNITRILE	SHIELDGLOVESMFR'S
BEFOREAGING	14.0 MPa	12.5 MPa	18.0 MPa	700%	500%	600%
AFTER AGING22 HRS @100°C	14.0 MPa	12.5 MPa	16.0 MPa	500%	400%	500%

Our Smart Shield™ Powder free, Colored Nitrile Gloves with Bubble Gum Scent meets all the current ASTM D 6319-99 standards for Nitrile Examination Gloves.

3. Water Tight Test

Using the FDA specified 1,000 ml water leak test, 200 pieces of each size of the gloves were tested following G1 single sampling plan and our results are as given below:

BATCH #	SIZE	SAMPLE SIZE	LEAK STATUS	NUMBERLEAKED
9904071315	Small	200	Yes	4
9904061313	Medium	200	Yes	1
9904061313	M-Large	200	Yes	2
9904061313	Large	200	Yes	3

The above meets the FDA Water Leak Test Requirements.

4. Biocompatibility

The test results below shows that the gloves meet FDA biocompatibility requirements:

BIOCOMPATIBILITY TESTS	RESULTS
Primary Dermal Irritation Test	Passes
Skin Sensitization Study	Passes

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5. Total Residual Powder Content & Presence of Cornstarch

TESTS	FDA INTERNALREQUIREMENTS	SHIELD GLOVES MFR'S
RESIDUAL POWDERCONTENTASTM D 6124	NOT EXCEEDING2 Mg PER GLOVE	RANGE:1.4-1.9 Mg/ GLOVEMEAN :1.7 Mg PER GLOVE
CORNSTARCH PRESENCE(IODINE TEST)	NEGATIVE	NEGATIVE

The glove conforms to FDA's proposed requirement not to exceed 2 mg/glove of total powder residue (using ASTM D 6124 Method for Residual Powder on Medical Gloves) and negative Iodine test.

CONCLUSION :-

It is concluded that the Smart Shield™ Powder Free, Colored Nitrile with Bubblegum scent gloves meet:-

ASTM D 3578-95 specifications.
FDA proposed requirement not to exceed 2 mg/glove of total powder residue per ASTM D 6124.
ASTM D 5151-90 Test Method for Detection of Holes in Medical Gloves
the FDA Water Leak Test requirements per ASTM D 5151.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, which is the department's emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 1999

Shield Gloves Manufacturer (M) Sdn. Bhd. c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114

Re : K991744 SMART SHIELD™ Powder-Free Blue Nitrile Trade Name: Examination Glove with Bubble Gum Scent Requlatory Class: I Product Code: LZA Dated: May 10, 1999 Received: May 21, 1999

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Mr. Smith

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowsk Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K991744

INDICATIONS FOR USE STATEMENT

Applicant: Shield Gloves Manufacturer (M) Sdn Bhd.

510K Number:

Device Name: SMART SHIELD TM Powder Free Colored Nitrile Examination Gloves With Bubblegum Scent

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

Over-The-Counter........X

Chin S. Lim

(Division Sign-Division of Dental, Int and General Hospita 510(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.