POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT EXAMINATION GLOVES

K960225 · Tillotson Healthcare Corp. · LYY · Jul 29, 1996 · General Hospital

Device Facts

• Record ID: K960225
• Device Name: POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT EXAMINATION GLOVES
• Applicant: Tillotson Healthcare Corp.
• Product Code: LYY · General Hospital
• Decision Date: Jul 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves with labeled protein content are suitable 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 Story

Disposable non-sterile patient examination glove; manufactured from natural latex rubber film. Provides barrier protection against body fluids and bloodborne pathogens. Designed for use by healthcare examiners. Features powder-free construction and labeled protein content to mitigate allergic sensitivity risks. Hypoallergenic designation supported by clinical patch testing. Used in clinical settings to prevent cross-contamination between patient and examiner.

Clinical Evidence

Clinical evidence consists of a Modified Draize Repeat Insult Patch Test conducted on 300 human subjects at three locations. Results showed no evidence of skin sensitization under study conditions. Non-clinical and pre-clinical testing included rabbit skin irritation and guinea pig sensitization studies, all of which passed. Physical performance testing confirmed compliance with ASTM standards for dimensions, properties, and water tightness.

Technological Characteristics

Natural latex rubber film; powder-free; 5-step washing/leaching process for protein reduction. Complies with ASTM standards for physical dimensions, physical properties, and water tightness. Non-sterile.

Indications for Use

Indicated for use by healthcare workers and patients as a protective barrier against body fluids and bloodborne pathogens, specifically for individuals with potential allergic sensitivities or those requiring powder-free environments.

Regulatory Classification

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.

Predicate Devices

• POWDER FREE PLUS PATIENT EXAM GLOVE (WITH LABELED PROTEIN CONTENT) (K954855)
• CUT RESISTANT GLOVE KIT WITH HYPOALLERGENIC INNER GLOVE (K910383)

Submission Summary (Full Text)

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TILLOTSON HEALTHCARE ID:6034710265 JUL 29 1996 JUL 26'96 12:34 No.004 P.07

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, 1996
REVISION DATE: JULY 26, 1996

# 510(K) SUMMARY

## (A) INFORMATION

### 1. SUBMITTER'S NAME
TILLOTSON HEALTHCARE CORPORATION

ADDRESS
360 Route 101
Bedford, NH 03110 USA

TELEPHONE NUMBER
[phone]

CONTACT PERSON
Imogene Tibbetts

DATE SUMMARY PREPARED
July 26, 1996

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

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

CLASSIFICATION NAME
Patient Examination Glove

### 3. PREDICATE DEVICE IDENTIFICATION
NAME, NUMBER
1. POWDER FREE PLUS PATIENT EXAM GLOVE
(WITH LABELED PROTEIN CONTENT),
K954855, SE 12/28/95
2. CUT RESISTANT GLOVE KIT
WITH HYPOALLERGENIC INNER GLOVE
#K910383

### 4. DESCRIPTION OF DEVICE
Patient examination gloves are made with intact natural latex rubber film, which provides a barrier to body fluids and bloodborne pathogens and between patient and examiner.

### 5. 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 on the examiner's hand to prevent contamination between patient and examiner. Gloves with labeled protein content are suitable 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.

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TILLOTSON HEALTHCARE
ID:6034710265
JUL 26'96
12:35 No.004 P.08

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, 1996
REVISION DATE: JULY 26, 1996

## 6. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE

### 1. SIMILARITIES

**Proposed and Predicate #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)

5 step washing/leaching process. | POWDER FREE PLUS
HYPOALLERGENIC (WITH LABELED
PROTEIN CONTENT)

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 suitable in situations where health care worker or patient allergic sensitivity may be a factor.

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TILLOTSON HEALTHCARE ID:6034710265 JUL 26'96 12:35 No.004 P.09

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, 1996

REVISION DATE: JULY 26, 1996

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

1. DISCUSSION OF NON-CLINICAL TESTS

| | POWDER FREE PLUS
(WITH LABELED PROTEIN
CONTENT)
PATIENT EXAMINATION GLOVE | POWDER FREE PLUS
HYPOALLERGENIC
(WITH LABELED PROTEIN
CONTENT)
PATIENT EXAMINATION GLOVE |
| --- | --- | --- |
| SPECIFICATION | PREDICATE | PROPOSED |
| 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 REPEAT
INSULT PATCH TEST ON
200 (300) HUMAN SUBJECTS
*Predicate #2* | Passed (# 2)
Predicate Product: Glove Kit, etc.
200 Human Subjects | Passes
Proposed Product: Hypoallergenic
300 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 ability to sensitize the skin of normal volunteer subjects using occlusive repeated insult patch study. About three hundred persons at three different locations completed the study. Under the conditions employed in this study, there was no evidence of sensitization.

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TILLOTSON HEALTHCARE ID:6034710265 JUL 26'96 12:36 No.004 P.10

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, 1996
REVISION DATE: JULY 26, 1996

4. 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 acceptable scores for the predicate products in physical, non-clinical and clinical tests.

Pursuant to 21 C.F.R. 807.87 (J), I Imogene Tibbetts, Director of Medical and Scientific 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 omitted from this submission.

Imogene Tibbetts
Director of Medical and Scientific Support Services

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