A Powder-Free Latex Examination Glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Patient Examination Gloves are a Class I device 21 CFR 880. They are used for wearing on hands of healthcare providers to prevent contamination from patient's or external environment.

The standards that are followed are as follows: ASTM 3578-00 and Food and Drug requirements for Patient Examination Gloves.

AI/ML Overview

The provided text describes the acceptance criteria and the methods used to demonstrate substantial equivalence for the "Safe Shield Powder-Free Latex Examination Gloves." Since this is a medical device (gloves), the "performance" metrics relate to physical properties and barrier integrity rather than a complex AI algorithm's diagnostic accuracy. Therefore, several points in your requested output (like MRMC studies, effect size of AI assistance, expert qualifications, etc.) are not applicable in this context.

Here's the breakdown of the information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Minimum)	Reported Device Performance (Minimum)	Test Method/Standard
Physical Dimensions:		ASTM 3578-00
Length: 230 mm	230 mm
Thickness: 0.08 mm	0.08 mm
Width (Small): $80 \pm 10$ mm	$80 \pm 10$ mm
Width (Medium): $95 \pm 10$ mm	$95 \pm 10$ mm
Width (Large): $110 \pm 10$ mm	$110 \pm 10$ mm
Physical Properties:
Before Aging:
Tensile Strength: 21 Mpa	21 Mpa	ASTM 3578-00
Ultimate Elongation: 700%	700%	ASTM 3578-00
After Aging:
Tensile Strength: 16 Mpa	16 Mpa	ASTM 3578-00
Ultimate Elongation: 500%	500%	ASTM 3578-00
Pin Hole (Water Tight Test):		1000 ml Water fill
AQL: 4.0	Meets AQL 4.0	21 CFR 800.20,
		MIL-STD-105E
Dimensions (Sampling/AQL):		MIL-STD-105E
AQL: 4.0	Meets AQL 4.0

Note: The text states "The physical specifications are as follows:" and then lists specific values for length, thickness, width, tensile strength, and ultimate elongation. These values are presented as minimums or exact specifications which the device must meet. The table above assumes the device met these exact listed values to claim substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The text refers to "Sampling and AQLs" for the Water Tight Test and Dimensions. For the Water Tight Test, it specifies "G-II" general inspection level and for Dimensions it specifies "S-2" special inspection level, derived from MIL-STD-105E. However, the exact number of units sampled for these tests is not explicitly stated in the provided text, only the inspection levels and AQLs.
Data Provenance: The text does not provide information about the country of origin of the data or whether the tests were retrospective or prospective. It implies the performance testing was conducted by Safe Shield Co. Ltd. in Thailand.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical barrier protection device (gloves), not an diagnostic device requiring expert interpretation for "ground truth." The "ground truth" for gloves is adherence to physical performance specifications and barrier integrity.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical or image-based studies, often involving expert readers. This is not relevant for the physical testing of examination gloves.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical glove, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a medical glove, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device is established by conformance to recognized standards and regulatory requirements for physical properties and barrier integrity.

Physical dimensions and properties: Based on ASTM 3578-00.
Pin hole testing (water tightness): Based on the FDA's "1000 ml Water fill test method" as described in 21 CFR 800.20, with sampling derived from MIL-STD-105E.

8. The sample size for the training set

Not applicable. There is no "training set" for physical testing of medical gloves. This term typically refers to data used to train machine learning models.

9. How the ground truth for the training set was established

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

Summary

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Attachment 11

510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is:________________________________________________________________________________________________________________________________________________

Submitter's Identification: 1.

Safe Shield Co. Ltd. 43/2, K.M. 28, Surat-Takuapa Road Tambon: Bangduen, Amphur: Phun Phin Suratthani 84100, Thailand

Contact: Mr. Krishan Kumar Dwivedy, Managing Director of Safe Shield

Date Summary Prepared: December 28, 2001

2. Name of the Device:

Safe Shield Powder-Free Latex Examination Gloves

Predicate Device Information: 3.

K#932550, Powder-Free Patient Examination Gloves, Safe-Glove Ltd., Glendale, AZ

4. Device Description:

Patient Examination Gloves are a Class I device 21 CFR 880. They are used for wearing on hands of healthcare providers to prevent contamination from patient's or external environment.

The standards that are followed are as follows: ASTM 3578-00 and Food and Drug requirements for Patient Examination Gloves.

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ട. Intended Use:

This powder-free latex examination glove is a disposable device intended for medical purposes in that it is worn on hands of health care providers or examiner's hand to prevent contamination between patient and examiner.

Comparison to Predicate Devices: 6.

The Safe Shield powder-free latex examination gloves are substantially equivalent in specifications, testing parameters, quality inspections and other physical attributes to Safe Gloves Co., Ltd. latex examination gloves and intended for same usages. There are no special labeling claims made for these gloves.

Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

The physical specifications are as follows:

Length:	230 mm minimum
---------	----------------

0.08 mm minimum Thickness:

Width:	Small:	$80 \pm 10$ mm
	Medium:	$95 \pm 10$ mm
	Large:	$110 \pm 10$ mm

Physical Properties: (Minimum)

	Before Aging	After Aging
Tensile Strength	21 Mpa	16 Mpa
Ultimate Elongation	700%	500%
Sampling and AQLs:
	Sampling	AQL

Water Tight Test	G-II	4.0
Dimensions	S-2	4.0

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Pin hole testing is done in conformance with Food and Drug PIN HOLE TESTING: Administration's requirement of 1000 ml Water fill test method as described in Paragraph (b) Test method of the final rule entitled Patient Examination gloves and test Method for leakage defects: Adulteration, 55 CFR 51256 -51258, 21 CFR 800.20, The sampling plan is derived from MIL-STD-105E (MILITARY STANDARD FOR SAMPLING PROCEDURES AND TABLES FOR INSPECTION BY ATTRIBUTES) based on General Inspection Level G II, normal inspection and acceptable quality level of 4.0

Discussion of Clinical Tests Performed: 8.

Not Applicable

9. Conclusions:

The Safe Shield powder-free latex examination gloves are substantially equivalent in specifications, testing parameters, quality inspections and other equivalont in openifications, toosing partitle powder-free latex examination gloves pnysioal and for same usages. There are no special labeling claims made for these gloves.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by three intertwined lines, resembling a stylized human form, which symbolizes health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

MAY 6 - 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Safe Shield Company Limited C/O Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck. New York 11021

Re: K020053

Trade/Device Name: Safe Shield Powder-Free Latex Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 17, 2002 Received: April 19, 2002

Dear Ms. Falk:

This letter corrects our substantially equivalent letter of May 1, 2002 regarding the company name.

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). 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 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 - Susan D. Goldstein-Falk

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 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. Ulatowski Director Division of Dental. Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.

INDICATIONS FOR USE

Safe Shield Co. Ltd. Applicant:

510(k) Number (if known):* __ Ko 20053

Device Name: _Safe Shield Powder-Free Latex Examination Gloves

Indications For Use:

A Powder-Free Latex Examination Glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Chiu S. Lin
(Division Sign Org.

Prescription Use _ OR Per 21 CRF 801.109 (Optional Format 11-2-96) Over-The-Counter _

(Division Sign-Off) Division of Dental, Infection Control, and General Hospjtal Devices 510(k) Number

For a new submission, do NOT fill in the 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.