This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to provent contamination between patient and examiner. Gloves with labeled protein are sultable In situations where health care worker or patient allergic sensitivity may be a factor. Powder free gloves are intended for use in situations where powder should not be used. Hypoallergenic gloves are appropriate for users who may have a previous sensitivity.

Device Description

Patient examination gloves are made with intect netural latex rubber film, which provides a barrier to body fluids and bloodborne pathogens and between patient and examiner.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device: "POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) Non-Sterile Patient Examination Glove." The submission aims to demonstrate that this new device is substantially equivalent to existing predicate devices.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Specification	Predicate Device Performance	Proposed Device Performance
Physical Dimensions	ASTM (Passes)	ASTM (Passes)
Physical Properties	ASTM (Passes)	ASTM (Passes)
Water Tightness	ASTM (Passes)	ASTM (Passes)
Rabbit Skin Irritation	Passes (#s 1 and 2)	Passes
Guinea Pig Sensitization	Passes (#s 1 and 2)	Passes
Modified Draize Repeat Insult Patch Test on Human Subjects	Passed (#2) - 200 subjects	Passes - 300 subjects
Hypoallergenic Labeling	Yes (Predicate #2)	Yes
Powder-Free	Yes (Predicate #1)	Yes
Labeled with Protein Content	Yes (Predicate #1)	Yes
Intended Use (Barrier to body fluids/bloodborne pathogens)	Yes	Yes
Intended Use (Suitable for allergic sensitivity)	Yes (Predicate #2)	Yes
Intended Use (Powder-free situations)	Yes (Predicate #1)	Yes

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

Human Subjects for Modified Draize Repeat Insult Patch Test:
- Proposed Device: 300 human subjects.
- Predicate Device #2: 200 human subjects.
Data Provenance: The document does not explicitly state the country of origin for the human subject tests. It mentions "About three hundred persons at three different locations completed the study," implying a prospective clinical test. For the physical and pre-clinical tests, the data provenance is implied to be from laboratory testing. It is a prospective clinical test for the human patch test.

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

The document does not specify the number or qualifications of experts involved in establishing the ground truth for the Modified Draize Repeat Insult Patch Test. It only states that the "study" was completed, implying observation and evaluation by qualified personnel, but the specific roles and qualifications are not detailed. For the ASTM tests and animal studies, these are standardized tests, and the "ground truth" is established by adherence to the protocol and the resulting measurements/observations, typically overseen by laboratory technicians and scientists.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (like 2+1, 3+1) for the human subject tests or any other tests. The "Passed" designation for the Modified Draize test implies a clear outcome based on predefined criteria for skin sensitization.

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 typically used to evaluate diagnostic imaging devices where human readers interpret results, and the document describes a glove, not an imaging device.

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

This concept is not relevant to the device described. The device is a physical medical glove, not an algorithm or AI system.

7. The Type of Ground Truth Used

Physical Dimensions, Physical Properties, Water Tightness: The ground truth is based on standardized ASTM (American Society for Testing and Materials) specifications and measurement outcomes.
Rabbit Skin Irritation & Guinea Pig Sensitization: The ground truth is based on standardized animal study protocols and observations of physiological reactions.
Modified Draize Repeat Insult Patch Test on Human Subjects: The ground truth is established through clinical observation of human subjects for signs of sensitization over a specified period, following a standardized protocol. This could be considered a form of clinical outcome data related to skin reactions.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development. This terminology is usually associated with AI/machine learning models. For a physical device like a glove, the development process involves iterative design and testing, but not typically a distinct "training set" as defined for AI. The manufacturing process is described as a "5 step washing/leaching process," which is identical to the predicate device, implying established manufacturing parameters rather than a data-driven training set.

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

As there is no explicit "training set" in the AI/ML sense, this question is not directly applicable. However, the manufacturing process, which could be seen as the "development" or "training" of the product, is based on the proven "5 step washing/leaching process" of the predicate device, implying that the "ground truth" for this process was established through prior successful manufacturing and performance of the predicate device.

Summary

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

JUL 29 1996

ID:6034710265

51QK) SUBMISSION FOR POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTENT) NO EXAM GLOVE

K960225

ORIGINAL SUBMISSION DATE: JANUARY 16, 1996 SUPPLEMENTAL SUBMISSION DATE: MAY 17, 1996 REVISION DATE: JULY 26, 1996

510(K) SUMMARY

360 Route 101

(603) 472-8600

Imogene Tibbetts

July 26, 1996

Bedford, NH 03110 USA

INFORMATION (A)
1. SUBMITTER'S NAME

ADDRESS

TELEPHONE NUMBER

CONTACT PERSON

DATE SUMMARY PREPARED

NAME OF DEVICE 2. TRADE OR PROPRIETARY NAME
POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) Non-Sterile Patient Examination Glove

TILLOTSON HEALTHCARE CORPORATION

COMMON OR USUAL NAME Non-Sterile Powder Free Patient Examination Glove

Patient Examination Glove

CLASSIFICATION NAME

PREDICATE DEVICE IDENTIFICATION 3. NAME, NUMBER
1. Powder Free Plus Patient Exam Glove (WITH LABELED PROTEIN CONTENT). K954855, SE 12/28/95
CUT RESISTANT GLOVE KIT 2. WITH HYPOALLERGENIC INNER GLOVE #K910383
ব . DESCRIPTION OF DEVICE Patient examination gloves are made with intect netural latex rubber film, which provides a barrier to body fluids and bloodborne pathogens and between patient and examiner.
STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR CONDITIONS ર્ડ THAT THE DEVICE WILL ADDRESS

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510(K) SUBMISSION FOR POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) NS EXAM GLOVE ORIGINAL SUBMISSION DATE: JANUARY 18, 1998 SUPPLEMENTAL SUBMISSION DATE: MAY 17, 1998 REVISION DATE: JULY 26, 1996

EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE છે.

1. SIMILARITIES

Proposed and Prodicate #1

The proposed product is physically identical to the predicate #1 in all respects. .
It is powder free, in the same way as its predicate #1. . Both predicate #1 and proposed will be labeled with protein content.
. The processing of the Proposed product Is Identical to Product #1.

PREDICATE	PROPOSED
POWDER FREE PLUS(WITH LABELED PROTEIN CONTENT)(#K954855 details on file)	POWDER FREE PLUSHYPOALLERGENIC (WITH LABELEDPROTEIN CONTENT)
5 step washing/leaching process.	5 step washing/leaching process.

Proposed & Predicate #2

. Both Predicate #2 and Proposed product have passed a Modified Draize Repeat Insult Patch Test on human subjects, and have been found hypoallergenic.
They are both labeled "Hypoallergenic". .

2. DIFFERENCES - LABELING: INTENDED USE

Proposed and Predicate #1

The labeling for both products will be the same, including all required label statements.

The difference is the statement, "Hypoallergenic" for the proposed.

The proposed product is sultable in situations where health care worker or patient allergic sensitivity may be a factor.

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

510(K) SUBMISSION FOR POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) NS EXAM GLOVE ORIGINAL SUBMISSION DATE: JANUARY 16, 1996 SUPPLEMENTAL SUBMISSION DATE: MAY 17, 1986 REVISION DATE: JULY 26, 1996

IF THE SE DECISION IS BASED ON PERFORMANCE DATA (B)

DISCUSSION OF NON-CLINICAL TESTS 1.

PHYSICAL DIMENSIONS	ASTM (Passes)	ASTM (Passes)
PHYSICAL PROPERTIES	ASTM (Passes)	ASTM (Passes)
WATER TIGHTNESS	ASTM (Passes)	ASTM (Passes)

2. DISCUSSION OF PRE-CLINICAL TESTS

SPECIFICATION	PREDICATE	PROPOSED
SAFETY
RABBIT SKIN IRRITATION	Passes ( #'s 1 and 2 )	Passes
GUINEA PIG SENSITISATION	Passes ( #'s 1 and 2 )	Passes

3. DISCUSSION OF CLINICAL TESTS

SPECIFICATION	PREDICATE	PROPOSED
MODIFIED DRAIZE REPEATINSULT PATCH TEST ON200 (300) HUMAN SUBJECTSPredicate #2	Passed (# 2 )Predicate Product: Glove Kit, etc.200 Human Subjects	PassesProposed Product: Hypoallergenic300 Human Subjects

DESCRIPTION OF SUBJECTS

For the Modified Draize Repeat Insult Patch Test, 300 human subjects were used.

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

Both the inside surface and the outside surface of POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) LATEX PATIENT EXAMINATION GLOVES were evaluated to determine their ablity to sensitize the skin of normal volunteer subjects using occlusive repeated insuit patch study. About three hundred persons at three different locations completed the study. Under the contions employed in this study, there was no evidence of sensitization.

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510(K) SUBMISSION FOR POWDER FREE PLUS HYPOALLERGENIC (MITH LABELED PROTEIN CONTENT) NS EXAM QLOVE ORIGINAL SUBMISSION DATE: JANUARY 18, 1998 SUPPLEMENTAL SUBMISSION DATE: MAY 17, 1996 REVISION DATE: JULY 26, 1996

CONCLUSIONS DRAWN FROM NON-CLINICAL, PRE-CLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY, EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT

The POWDER FREE PLUS HYPOALLERGENIC LATEX EXAM GLOVE (WITH LABELED PROTEIN CONTENT) has been compared to legally marketed devices in the 510(k). The data summaries Indicate that the proposed product meets accessfor the predicate products in physical, non-cilnical and clinical tests.

Pursuant to 21 C.F.R. 807.87 ( ) }, I Imogene Tibbetts, Director of Medical and Scientlific Support Services, 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 Director of Medical and Scientific Support Services 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 ornitted from this submission.

Lorene Tibbetts

Imogene Tibbetts Director of Medical and Scientific Support Services

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.