The Powder Free, Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).
Low protein claim surgical gloves are suitable in situations where healthcare worker or patient allergic sensitivity may be a factor. Powder free gloves are intended for use in situations where powder is not desirable.

Device Description

Natural Rubber Latex films form an excellent barrier to body fluids and bloodborne pathogens. The latex rubber is water tight under normal conditions of use. It's tensile strength allows for movements necessary for medical treatment. Natural Rubber Latex is known to create a superior barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D3578 and ASTM D5151 requirements.

AI/ML Overview

The provided text describes the 510(k) submission K974065 for a Powder Free, Examination Glove (with low protein claim). This submission is for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing against established standards, rather than complex studies involving human readers or AI.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Device Performance (Proposed Device)	Study that Proves Device Meets Criteria
Performance Standard	ASTM D3578	Non-clinical tests against ASTM D3578
Water Tightness	ASTM D5151	Non-clinical tests against ASTM D5151
Protein Content (low protein claim)	ASTM D5712 (50 micrograms or less of total water extractable protein per gram)	Non-clinical tests against ASTM D5712
Safety (Rabbit Irritation)	Passes	Clinical tests (Rabbit Irritation)

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

Sample Size: Not explicitly stated for each specific test (e.g., number of gloves tested for water tightness or protein content). The submission implies that sufficient samples were tested to demonstrate compliance with the ASTM standards.
Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are "non-clinical tests" and "clinical tests" used to demonstrate equivalence, implying they were conducted specifically for this submission. The submitter is Tillotson Healthcare Corporation, located in Bedford, NH, U.S.A., so it's reasonable to infer the testing was likely conducted in the U.S. or at labs compliant with U.S. standards. The "clinical tests" for safety (rabbit irritation) would typically be prospective for a new device submission.

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

Not applicable. This device is an examination glove, and the "ground truth" is established by adherence to recognized ASTM consensus standards (D3578, D5151, D5712) and a standard safety test (Rabbit Irritation Test). These standards define objective pass/fail criteria, not subjective expert judgment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation is against objective, pre-defined ASTM standards, not subjective assessments requiring adjudication by multiple experts.

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

No. This submission is for a physical medical device (an examination glove), not an AI or imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not relevant or applicable.

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

No. This submission is for a physical medical device. The concept of an "algorithm only" or "standalone" performance test is not applicable to an examination glove.

7. The Type of Ground Truth Used

The ground truth used is based on consensus standards and objective physical/chemical measurements:

ASTM D3578: Standard Specification for Rubber Examination Gloves. This defines physical properties like tensile strength and elongation.
ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves. This defines water-tightness criteria.
ASTM D5712: Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method. This defines the method and criteria for low protein claims.
Rabbit Irritation Test: A standard biological test to assess skin irritation (a form of adverse effect on biological systems).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set." The device is manufactured according to specifications and then tested against established standards.

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

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

Summary

{0}------------------------------------------------

K974065
JAN. 4, 1998

SUMMARY OF 510(k) Submission # K97

INFORMATION A.
- 1. SUBMITTER'S
  - NAME:

ADDRESS:

TELEPHONE NUMBER:

CONTACT PERSON:

DATE SUMMARY PREPARED:

1. NAME OF DEVICE TRADE OR PROPRIETARY NAME:
  COMMON OR USUAL NAME:

CLASSIFICATION NAME:

1. PREDICATE DEVICE IDENTIFICATION NAME, NUMBER
  360 Route 101

TILLOTSON HEALTHCARE CORPORATION

Bedford, NH 03110 U.S.A.

(603) 472-6600

Edward Markovic

October 17, 1997

Powder Free, Examination Glove

Examination Glove

Powder Free, Hype 1 1 4 1

Examination Glove KI (with low protein claim)

(which low protein grain)

1. DESCRIPTION OF DEVICE
- DESCRIF TION DEVICE FUNCTIONS: HOW THE DEVICE FUNCTIONS:
  Natural Rubber Latex films form an excellent barrier to body fluids and bloodborne pathogens.
- b. SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE:
- SCIENTIFIC CONCEPTS THAT FORM THE BADIC HONDANIA of use. It's tensile The latex rubber is water tight under normal concreases of ovements necessary for medical treatment.

PHYSICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN, MATERIALS

C. PHYSICAL AND PERFORMANCE
AND PHYSICAL PROPERTIES:
Natural Rubber Latex is known to create a superior barrier to bloodborne pathogens and
and body fluids. ASTM conforming tensile properties create a glove that is strong
and flexible. The leaching process removes traces of chemical accelerants that
may be chemically irritating. The glove is manufactured in accordance with the
requirements of ASTM D3578 and ASTM D5151 requirements.

{1}------------------------------------------------

SUMMARY OF SAFETY AND EFFECTIVENESS (cont.)

1. STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR conditions that the device will address

This is a disposable device, intended for medical purposes, that is worn onthe examiner's hand to prevent contamination between patient and examiner.
Low protein claim surgical gloves are suitable in situationswhere healthcare worker or patient allergic sensitivity may be a factor. Powder freegloves are intended for use in situations where powder is not desirable.

1. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE

. The proposed product is identical to the predicate product and isThe first of the country of the consisted on the consisted on the comments of the comments of the comments of the comments of the comments of the comments of the comments of
sultable for situations where a low sensitizing glove is desirable.

· It is powder free, (with low protein claim) in the same way as predicate product.

B. IF SE DECISION BASED ON PERFORMANCE DATA

1. DISCUSSION OF NON-CLINICAL TESTS

SPECIFICATION	PROPOSED	PREDICATE
	Powder Free(low protein)	Powder FreeHypoallergenic(low protein)
PERFORMANCESTANDARDS	ASTM D3578	ASTM D3578
WATER TIGHTNESS	ASTM D5151	ASTM D5151
PROTEIN	ASTM D5712	ASTM D5712
DISCUSSION OF CLINICAL TESTS
SPECIFICATIONSAFETYRABBIT IRRITATION	Passes	Passes

{2}------------------------------------------------

SUMMARY OF SAFETY AND EFFECTIVENESS (cont.)

DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED with specific reference to adverse effects and complications

1. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE CONCEGSIONS DRAWN PROM PERFORMANCE =/> PREDICATE PRODUCT
  The Powder Free, Hypoallergenic Examination Glove has been carefuly compared The Powder Free, I rypocas in the 510(k). The data summaries indicate that the propolsed w again managed acceptable scores for the prodicate product in nonclinical tests, and satisfies the requirements for a safe and effective powder free, hypoallergenic medical glove.

Pursuant to 21 C.F.R. 807.87 ( ) ), I, Edward Markovic, Manager QA/Regulatory Affairs certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as the Manager QA/Regulatory Affairs for TILLOTSON HEALTHCARE CORPORATION. and in reliance thereupon, the data and information submitted in this premarket notification are truthful and accurate and that no facts material to a review of the substantial equivalence of this device have been knowingly omitted from this submission.

Edward Markovic Manager QA/Regulatory Affairs

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 6 1998

Mr. Edward Markovic Manager Quality Assurance/Regulatory Affairs Tillotson Healthcare Corporation 360 Route 101 03110 Bedford, New Hampshire

K974065 Re : Powder Free Latex Examination Glove (with Trade Name: Protein Claim) 50 micrograms or less of total water extractable protein per gram Regulatory Class: I Product Code: LYY Dated: October 17, 1997 Received: October 27, 1997

Dear Mr. Markovic:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

{4}------------------------------------------------

Page 2 - Mr. Markovic

not affect any obligation you might have under sections 531 not arrece any obangat for devices under the Electronic ciffough 542 or cho notrol 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 described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate anits 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" (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.gov/cdrh/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

{5}------------------------------------------------

510(k) Number (if known):

Page 1 of 1

Device Name:

on Glove beling claim) h com ins 60 microarams or loss This glove com of total water extractable protein per gram.

510/k) 974065

Indications For Use:

The Powder Free, Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).

(PLEASE DO NOT WRITE BELOW THIS LINE

CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)		Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number	V974065
Prescription Use		Over-The-Counter Use	X

(Per 21 CFR 801.109)

.................

ﺗ

ﻪ ﺳ

Over-The-Counter Use X

(Optional Format 1-2-98)

REVISED Section B (2) INDICATIONS FOR USE NSO9001\REGUL\510KVK974086\KCLOR.XLS

、

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.