ULTRA CARE POWDER FREE HYPOALLERGENIC PATIENT EXAMINATION GLOVE

K960247 · Tillotson Healthcare Corp. · LYY · Jul 29, 1996 · General Hospital

Device Facts

• Record ID: K960247
• Device Name: ULTRA CARE POWDER FREE HYPOALLERGENIC PATIENT EXAMINATION GLOVE
• 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

Indications for 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. Hypoallergenic patient examination 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 should not be used.

Device Story

Disposable natural latex rubber examination glove; provides barrier between patient and examiner to prevent cross-contamination. Features proprietary polyurethane 'slip coat' to eliminate need for donning powder; includes two additional leaching steps during manufacturing to reduce potential allergens. Used in clinical settings by healthcare professionals. Hypoallergenic status confirmed via Modified Draize Repeat Insult Patch Test. Benefits include reduced risk of powder-related complications and allergic reactions for sensitive users.

Clinical Evidence

Clinical safety evaluated via Modified Draize Repeat Insult Patch Test on 300 human subjects. Study assessed skin sensitization potential of both inner and outer glove surfaces. Results showed no evidence of sensitization under study conditions.

Technological Characteristics

Natural latex rubber film; polyurethane slip coat; powder-free. Meets ASTM standards for water tightness, tensile strength, and elongation. Manufacturing process includes two additional leaching steps compared to standard latex gloves.

Indications for Use

Indicated for use by healthcare workers as a protective barrier against body fluids and bloodborne pathogens during patient examinations. Suitable for patients or clinicians with allergic sensitivity to standard examination gloves.

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

• Formula One Patient Exam Glove (K891939)
• Sensi Shield Glove Kit, Inner Glove (K910383)

Submission Summary (Full Text)

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TIL:OTSON HEALTHCARE ID:6034710265 JUL 26'96 12:32 No.004 P.04

JUL 29 1996

510(K) SUMMARY

K960247

A. INFORMATION

1. SUBMITTER'S

NAME: TILLOTSON HEALTHCARE CORPORATION

ADDRESS: 360 Route 101
Bedford, NH 03110 U.S.A.

TELEPHONE NUMBER: [phone]

CONTACT PERSON: Imogene Tibbetts

DATE SUMMARY PREPARED: December 27, 1995

2. NAME OF DEVICE

TRADE OR PROPRIETARY NAME: Ultra Care Powder Free Hypoallergenic
Non-Sterile Examination Glove

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

CLASSIFICATION NAME: Patient Examination Glove

3. PREDICATE DEVICE IDENTIFICATION

NAME, NUMBER: 1. Formula One Patient Exam Glove K891939
2. Sensi Shield Glove Kit, Inner Glove, K910383
(Hypoallergenic)

4. DESCRIPTION OF DEVICE

Patient examination gloves are made with an 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.

Hypoallergenic patient examination 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 should not be used.

6. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE

- The proposed product is identical to the predicate product #1 in the following respects:

1. SPECIFICATIONS, ESPECIALLY WATER TIGHTNESS

The specifications for both gloves are identical with respect to water tightness and all physical parameters such as tensile and elongation. Results of testing demonstrate equivalence.

2. FORMULATION OF LATEX

- The formulation for the latex layer is identical in the proposed and predicate #1 gloves.

3. IT IS HYPOALLERGENIC

- Both Predicate #2 and Proposed product have passed a Modified Draize Repeat Insult Patch Test on human subjects, and have been found hypoallergenic.

- The proposed product is different from the predicate product #1 in the following respects:

1. FORMULATION/PROCESSING - METHOD FOR RENDERING GLOVE powder free.

The proposed product has an additional "slip coat" composed of a proprietary polyurethane coating, as a substitute for donning powder.

2. NO DONNING POWDER is added.

3. PROCESSING

The proposed product has two extra leach steps in its process.

4. LABELING: INTENDED USE

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

The main differences from predicate #1 are the statements "Powder Free" and "Hypoallergenic".

Section P (revision) - 510(K) SUMMARY

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TILLOTSON HEALTHCARE ID:6034710265 JUL 26'96 12:33 No.004 P.05

510(K) SUBMISSION FOR ULTRA CARE POWDER FREE HYPOALLERGENIC NS PATIENT EXAM GLOVE
ORIGINAL SUBMISSION DATE: JANUARY 9, 1996
SUPPLEMENTAL SUBMISSION DATE: MAY 17, 1996
REVISION DATE: JULY 26, 1996

510(K) SUMMARY (continued)

B. IF SE DECISION BASED ON PERFORMANCE DATA

1. DISCUSSION OF NON-CLINICAL TESTS

SPECIFICATION

| PREDICTIVE | PROPOSED |
| --- | --- |
| 1. Formula One
Patient Examination Glove | Ultra Care Powder Free
Hypoallergenic
Patient Examination Glove |
| 2. Renal Shield Glove Kit
Hypoallergenic Inner Glove | ASTM |
| ASTM ( #1 ) | ASTM |
| ASTM ( #1 and #2 ) | ASTM |
| PERFORMANCE STANDARDS | |
| WATER TIGHTNESS | |
| Passes ( #1 and #2 ) | Passes |
| Passes ( #1 and #2 ) | Passes |
| on 200 human subjects | on 300 human subjects |

2. DISCUSSION OF CLINICAL TESTS

SPECIFICATION

SAFETY

RABBIT SKIN IRRITATION

GUINEA PIG SENSITIZATION

MODIFIED DRAIZE REPEAT

INSULT PATCH TEST

DESCRIPTION OF SUBJECTS

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 Ultra Care Powder Free Hypoallergenic 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

3. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE = / > PREDICATE PRODUCT

The Ultra Care Powder Free Hypoallergenic Exam Glove 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, nonclinical and clinical tests.

Pursuant to 21 C.F.R. 807.87 ( ), 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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Section P (revision) - 510(K) SUMMARY

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