SAFESKIN

K962139 · Safeskin Corp. · LZA · Dec 19, 1996 · General Hospital

Device Facts

• Record ID: K962139
• Device Name: SAFESKIN
• Applicant: Safeskin Corp.
• Product Code: LZA · General Hospital
• Decision Date: Dec 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient’s body, fluids, waste or environment.

Device Story

Nitrile examination glove; powder-free; non-sterile. Worn by healthcare personnel to provide barrier protection against contamination. Device functions as a physical barrier; no active components. Manufactured from nitrile material; incorporates colorant. Evaluated for biocompatibility and physical integrity via water leak testing. Intended for use in clinical settings to reduce cross-contamination risk between patients and healthcare workers.

Clinical Evidence

Clinical evidence consists of a 200-person Modified Draize test conducted to support the hypoallergenic claim. The study evaluated primary or cumulative irritation and sensitization potential via epidermal contact on the upper back. The test involved ten induction applications followed by a two-week rest and two challenge patches. Results demonstrated no significant irritation or sensitization potential.

Technological Characteristics

Nitrile examination glove; powder-free; non-sterile. Complies with ASTM D3578-91 and ASTM D5250-92. Biocompatibility testing per Tripartite Guidance (Primary Dermal Irritation, Buehler Dermal Sensitization). Physical testing includes 1,000 mL FDA Water Leak Test (21CFR 800.20(b)(1)).

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent contamination between the wearer and the patient's body, fluids, waste, or environment.

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

• Safeskin Nitrile patient examination glove (K932404)

Submission Summary (Full Text)

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DEC 19 1996
K962139
Safeskin Corporation
Submitted: May 28, 1996
Contact: Michelle Molloy
12671 High Bluff Drive
San Diego, California 92130
Phone: [phone]
Fax: [phone]

# Attachment 8
## 510(k) Summary
## of Safety and Effectiveness

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Safeskin Corporation
12671 High Bluff Drive
San Diego, California 92130
Tel: [phone]
[phone]
Fax: [phone]

# Hypoallergenic Powder-Free Nitrile Examination Gloves

## 510 (K) SUMMARY of Safety and Effectiveness

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

1. [807.92(c)] Separate Document

2. [807.92(a)] Applicant: Safeskin Corporation
12671 High Bluff Drive
San Diego, California 92130
Phone: [phone]
Fax: [phone]

Contact: Michelle Molloy
Safeskin Corporation
12671 High Bluff Drive
San Diego, California 92130
Phone: [phone]
Fax: [phone]

3. [CFR 880.6250] Date Summary Prepared: May 28, 1996

**Name of Device:**
- Proprietary Name: Safeskin
- Common Name: Nitrile exam gloves
- Classification: Patient examination glove (per 21CFR 880.6250)

4. [807.92 (a)(3)] Equivalence:
The legally marketed device to which equivalence is claimed is K932404 (Safeskin) a Class I Nitrile patient examination glove 80 FMC.

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5. [807.92(a)(4)]

**Description:**

This Class I Nitrile patient examination glove (80FMC) is powder-free and meets all the requirements of ASTM Standard D 3578-91 with the exception of pre-aged ultimate elongation. This applicant glove, does however, far exceed the requirements for the only synthetic (non-natural latex) examination glove requirements as described in ASTM D 5250-92. The glove is the same product to which equivalence is claimed, K932404 (Safeskin), except colorant and the Hypoallergenic claim have been added.

**Similarity and Differences**

Comparison Between Safeskin’s K932404

and This New Submission

| | Same | Different |
| --- | --- | --- |
| Formulation | ☑ | |
| Processing | ☑ | |
| Powder-Free | ☑ | |
| Non-Sterile | ☑ | |
| Biocompatibility | ☑ | |
| Physical Testing | ☑ | |
| Hypoallergenic | | ☑ |
| Colorant | | ☑ |

6. [807.92(a)(5)]

**Intended Use:**

A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient’s body, fluids, waste or environment.

7. [807.92(a)(6)]

**Technological Characteristics of applicant device compared to predicate device; non-clinical performance data:**

Both gloves comply with ASTM 3578-91 Standard and the FDA Water Leak Test.

A. Gloves comply with ASTM D3578-91 and FDA 1,000 mL Water Leak requirement.

B. The powder-free assessment which follows is based upon the procedure:

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Tests for Particulates by Weight and Iodine Color as described on pg. 5.54 in Regulatory Requirements for Medical gloves by the Division of Small Manufacturers Assistance, CDRH, FDA, May 1993.

| B. Powder-free Assessment | | COMPARISON | |
| --- | --- | --- | --- |
| | | K932404 | Applicant Device |
| Residue weight | ≤ 2 mg | same glove | same glove |
| Results of iodine assay (cornstarch) | < 5 mg | same glove | same glove |
| C. Biocompatibility
As recommended by the Tripartite Guidance on Biocompatibility of Medical Devices | COMPARISON
K932404
Applicant Device | |
| --- | --- | --- |
| | Pass/Fail | |
| • Primary Dermal Irritation
Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 | Pass | Pass |
| • Dermal Sensitization (Buehler) Study
ASTM Standard F 720-81
(Reapproved in 1986) | Pass | Pass |
| • 200 Person Modified Draize Test
DSMA Regulatory Requirements for Medical Gloves, May 1993. | Not tested | Pass |

8. [807.92(a)(c)] Non-clinical performance data:

A summary of results of non-clinical performance evaluations is presented above. A brief description of these tests follows:

A: Dimensional and Physical Properties.

ASTM D3578-91 specifies the dimensional measurement requirements including thickness to which the Applicant and K932404 gloves comply, unless otherwise noted.

1,000 mL FDA Water Leak Test consists of attaching a glove over the end of a plastic cylinder and dispensing 1,000 mL of water into the glove. Leaks within a two-minute period are recorded as failures. Testing is performed according to 21CFR 800.20 (b)(1). Sampling is performed utilizing Mil Std. 105E or an increased sampling tightness when deemed appropriate. Applicant glove and K932404 meet this FDA requirement.

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B: The powder-free test method is an assay, described as recommendations in the Regulatory Requirements for Medical gloves by the Division of Small Manufacturers Assistance, CDRH, FDA May, 1993. A water extract of the gloves is filtered, dried and the residue weighed to determine the total particulate removed from the glove. Applicant glove and K932404 demonstrate very low particulate/cornstarch levels; however, no standards have been set by the FDA or the ASTM.

C: Biocompatibility.

Primary Dermal Irritation. The testing is performed according to the regulations of the Consumer Product Safety Commission, Title 16, Chapter II, Part 1500. The purpose of the study is to determine the dermal irritation potential of the glove to the shaved intact and abraded skin on the backs of albino rabbits. Appropriate controls were conducted. Applicant glove showed no significant irritancy potential.

Dermal Sensitization (Buehler) Study. This study is performed on fifteen young adult Hartley Guinea Pigs (male) per extract to determine the sensitization potential of the gloves. Safeskin Powder-Free Nitrile Exam Gloves were tested with Dinitrochlorobenzene (DCNB) used for a positive control substance. A one inch square patch of test material was applied to clipped areas of the test animals, once weekly for three weeks, six hours per exposure. Erythema and edema were scored according to Draize evaluation. The Challenge phase was conducted two weeks after the last administration of induction dose in the same manner as previously described. Appropriate controls were conducted. Applicant glove showed no significant sensitization potential.

9. [807.92(b)(2)]

Clinical Performance Data:

The 200 person Modified Draize Test was performed on the applicant glove to comply with FDA requirements for obtaining the Hypoallergenic claim. This test was conducted to determine by epidermal contact the primary or cumulative irritation and/or sensitization potential of the test material. Test site was the upper back between the scapulae. Test sample portions of the glove were attached to the back. This procedure was followed three times per week for a total of ten applications. Observations and scoring were made at each test period. Following a two-week rest period, two consecutive challenge patches of the test material were applied to a different site on the scapular back under occlusive patches.

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10. [807.92 (b)(3)]

Conclusions drawn from the non-clinical and clinical tests in 7, 8, and 9 above:

The applicant glove meets or exceeds ASTM standards, FDA pinhole requirements and labeling claims as demonstrated in 7, 8, and 9 above.

11. [807.92 (d)]

Other information deemed necessary by the FDA.

No other information has been requested at this time.

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