ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES

K964474 · Allegiance Healthcare Corp. · KGO · Mar 11, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964474
• Device Name: ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES
• Applicant: Allegiance Healthcare Corp.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Mar 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Indications for Use

Ultrafree Sterile Latex Powder-Free Surgical Gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Sterile, powder-free surgical gloves; composed of natural rubber latex; intended for use by operating room personnel in hospitals/healthcare facilities; provides barrier protection for surgical wounds during invasive and non-invasive procedures; prevents contamination between patient and clinician.

Clinical Evidence

Bench testing only. Biocompatibility: primary skin irritation (negative), systemic toxicity (negative), intracutaneous reactivity (none), hemocompatibility (no lysis), guinea pig maximization (no irritation). Physical: tensile strength/elongation meet ASTM D3577-91; barrier defects meet 21 CFR §800.20 (AQL 2.5); powder-free status verified via vacuum filtration (<2 mg/glove) and negative iodine test.

Technological Characteristics

Material: natural rubber latex. Form factor: surgical glove. Performance standards: ASTM D3577-91 (tensile strength/elongation), 21 CFR §800.20 (barrier integrity). Designation: powder-free (vacuum filtration/iodine test). Sterilization: sterile.

Indications for Use

Indicated for use by operating room personnel during invasive and non-invasive medical procedures requiring a sterile barrier to protect surgical wounds from contamination.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Triflex® Sterile Latex Powder-Free Surgical Gloves

Submission Summary (Full Text)

{0}

MAR 11 1997
K964474

# XIV. SUMMARY OF SAFETY AND EFFECTIVENESS

## Allegiance

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
### ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES

**Manufacturer:**
Allegiance Healthcare Sdn. Bhd.
Plot 87 Kampung Jawa
11900 Bayan Lepas
Penang, West Malaysia

**Regulatory Affairs Contact:**
Maryalice Smith
Allegiance Healthcare Corporation
1500 Waukegan Road, Bldg. K
McGaw Park, IL 60085

**Telephone:** [phone]

**Date Summary Prepared:** February, 1997

**Product Trade Name:** Ultrafree Sterile Latex Powder-Free Surgical Gloves

**Common Name:** Surgical Glove

**Classification:** Glove, Surgical

**Predicate Devices:** Triflex® Sterile Latex Powder-Free Surgical Gloves

**Description:** The Ultrafree Surgical gloves are formulated using natural rubber latex and offered sterile.

**Intended Use:** Ultrafree Sterile Latex Powder-Free Surgical Gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.

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## Substantial Equivalence:

The Ultrafree Sterile Latex Powder-Free Surgical Gloves are substantially equivalent to Triflex® Sterile Latex Powder-Free Surgical Gloves in that they provide the following characteristics:

- intended use
- size, configuration, packaging
- made of natural rubber latex
- tensile strength and thickness profiles

## Summary of Testing:

| Test | Result |
| --- | --- |
| Primary Skin Irritation | Glove does not display any potential for irritation. |
| Systemic Toxicity | Glove does not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | No reactivity was observed. |
| Hemocompatibility | Gloves are hemocompatible exhibiting no lysis. |
| Guinea Pig Maximization | Glove does not display any potential for irritation. |
| Ultimate Elongation & Tensile Strength | Glove meets or exceeds requirements for rubber surgical gloves per ASTM D3577-91. |
| Barrier Defects | Glove meets or exceeds requirements per 21 CFR §800.20, AQL = 2.5. |
| Data/Test Method | Glove meets powder level requirements for “Powder Free” designation using the vacuum filtration method plus a negative iodine test. Results generated values below the 2 mg/glove cornstarch level including negative iodine test. |