A Pre-Powdered 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. These gloves are pre-powdered with a PMA approved Corn Starch Powder. They are used for wearing on hands of healthcare providers to prevent contamination from patient's or external environment.

AI/ML Overview

This document describes the acceptance criteria and the study conducted for the Safe Shield Pre-Powdered Latex Examination Gloves (K013980).

The device in question, a pre-powdered latex examination glove, is a Class I medical device, which typically does not require extensive clinical studies to demonstrate safety and effectiveness. Instead, substantial equivalence to a predicate device is shown through non-clinical performance testing against recognized standards.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The study for this device primarily involved non-clinical performance testing against established standards. The acceptance criteria are derived from ASTM 3578-00 and Food and Drug requirements for Patient Examination Gloves, as well as specific MIL-STD-105E AQLs. The document presents the physical specifications and properties as "minimums," implying these are the acceptance criteria, and the device is implied to meet or exceed these values.

Criterion	Acceptance Criteria (Minimum)	Reported Device Performance (Implied Met)
Physical Specifications:
Length	230 mm	Met (as implied by substantial equivalence)
Thickness	0.08 mm	Met (as implied by substantial equivalence)
Width (Small)	80 ± 10 mm	Met (as implied by substantial equivalence)
Width (Medium)	95 ± 10 mm	Met (as implied by substantial equivalence)
Width (Large)	110 ± 10 mm	Met (as implied by substantial equivalence)
Physical Properties (Before Aging):
Tensile Strength	21 Mpa	Met (as implied by substantial equivalence)
Ultimate Elongation	700%	Met (as implied by substantial equivalence)
Physical Properties (After Aging):
Tensile Strength	16 Mpa	Met (as implied by substantial equivalence)
Ultimate Elongation	500%	Met (as implied by substantial equivalence)
Sampling and AQLs:
Water Tight Test (AQL)	2.5 (G-II sampling)	Met (as implied by conformance with FDA requirement/MIL-STD-105E)
Dimensions (AQL)	4.0 (S-2 sampling)	Met (as implied by conformance with ASTM/FDA requirements)
Physical Properties (AQL)	4.0 (S-2 sampling)	Met (as implied by conformance with ASTM/FDA requirements)
Pin Hole Testing (AQL)	4.0 (G-II sampling, normal inspection)	Met (as implied by conformance with FDA 1000ml water fill test and MIL-STD-105E)

2. Sample size used for the test set and the data provenance

Sample Size: The document refers to sampling plans based on MIL-STD-105E, specifically "General Inspection Level G II, normal inspection and acceptable quality level of 4.0" for Pin Hole Testing, and "G-II" for Water Tight Test (AQL 2.5), and "S-2" for Dimensions and Physical Properties (AQL 4.0). However, the specific number of units tested (sample size in concrete numbers for each test) is not explicitly stated. MIL-STD-105E defines sample sizes based on lot size and inspection level, but these actual numbers are not provided in the summary.
Data Provenance: The data is generated from tests performed by the manufacturer, Safe Shield Co. Ltd. The country of origin for the data generation would be Thailand, where the company is located. The testing is prospective in the sense that it's performed on newly manufactured devices to demonstrate compliance for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This device is a Class I glove, and its performance is assessed through objective physical and chemical testing against established standards (ASTM, FDA regulations, MIL-STD). There is no "ground truth" established by human experts in the way it would be for an AI diagnostic device. The performance is determined by measurable physical properties.

4. Adjudication method for the test set

Not Applicable. As mentioned above, there's no human adjudication involved in determining the test results for physical properties of gloves. The tests are objective and follow standard protocols (e.g., water fill test, tensile strength measurement).

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 is a physical device (examination glove), not an AI software. Therefore, an MRMC study or any assessment of AI assistance is irrelevant.

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

Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective, measurable physical properties defined by:

ASTM 3578-00 standard for latex examination gloves,
Food and Drug Administration (FDA) requirements for Patient Examination Gloves (including the 1000 ml Water fill test described in 21 CFR 800.20), and
MIL-STD-105E for sampling and acceptable quality levels (AQLs).

These are established industry and regulatory standards for glove quality.

8. The sample size for the training set

Not Applicable. "Training set" is a concept typically used for AI/machine learning models. This device is a physical product and does not involve any machine learning for its function or performance assessment. Its manufacturing process would be subject to quality control, but not a "training set" in the computational sense.

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

Not Applicable. See point 8.

Summary

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Attachment 3

510(K) SUMMARY

This summary of 510(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: K 013980

1. Submitter's Identification:

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: April 17, 2002

2. Name of the Device:

Safe Shield Pre-Powdered Latex Examination Gloves

3. Predicate Device Information:

K#973831, Pre-Powdered Patient Examination Gloves, Safe-Glove Ltd., Glendale, AZ

4. Device Description:

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

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5. Intended Use:

This 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.

6. Comparison to Predicate Devices:

The Safe Shield 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
Thickness: 0.08 mm minimum

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	2.5
Dimensions	S-2	4.0
Physical Properties	S-2	4.0

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PIN HOLE TESTING: Pin hole testing is done in conformance with Food and Drug 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

8. Discussion of Clinical Tests Performed:

Not Applicable

9. Conclusions:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an image of three stylized human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

. Jun 6 2002

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

Re: K013980

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

Dear Ms. Flak:

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 vour 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.

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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 (OS) 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,

Susan Runoor
Timothy A. Ulatowski

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:

K013980 510(k) Number (if known):* ___________________________________________________________________________________________________________________________________________________

Device Name: _Safe Shield Pre-Powdered Latex Examination Gloves

Indications For Use:

A Pre-Powdered 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)

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

For a new submission, do NOT fill in the 510(k) number.

Clain S. Lim

(Division Sign-Off) Division of Dental, Infection Control, e & General Hospital Devi to for thember -

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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.