MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES

K962986 · Johnson & Johnson Medical, Inc. · KGO · Sep 20, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962986
• Device Name: MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES
• Applicant: Johnson & Johnson Medical, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

MAXXUS Powder Free Orthopaedic Latex Surgical Gloves are intended to protect the wearer from liquids such as body fluids and blood, as well as to protect surgical wounds or sterile fields from microbiological contamination from the wearer.

Device Story

Sterile, brown, powder-free latex surgical gloves; worn by surgeons and clinical staff in OR/sterile environments; provide barrier protection against blood, body fluids, and cross-contamination; manufactured via rubber latex compounding; non-powdered to reduce potential for starch-related complications.

Clinical Evidence

No clinical tests conducted. Bench testing performed per ASTM D-3577-91 and 21 CFR 800.20. Biocompatibility confirmed via rabbit primary skin irritation and guinea pig delayed contact sensitization studies. USP iodine test confirms absence of starch.

Technological Characteristics

Type 1 rubber latex surgical gloves; ASTM D-3577-91 compliant; brown color; non-powdered; sterile; sizes 5.5-9.0.

Indications for Use

Indicated for use by healthcare personnel as a protective barrier against body fluids, blood, and microbiological contamination during surgical procedures.

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

• MAXXUS Orthopaedic Latex Surgical Gloves (K962986)

Submission Summary (Full Text)

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# SEP 20 1996

510(k) Summary

MAXXUS* POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES

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k962986

| Submitter's Name: | Johnson & Johnson Medical Inc. |
| --- | --- |
| Submitter's Address: | 2500 Arbrook Blvd.
Arlington, Texas 76014 |
| Submitter's Phone Number: | [phone] |
| Submitter's Fax Number: | [phone] |
| Name of Contact Person: | Margaret Marsh |
| Date of Preparation: | September 17, 1996 |
| Name of Device: | |
| Trade Name: | MAXXUS* Powder Free Orthopaedic Latex Surgical Gloves |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves |
| Legally Marketed Device to Which Equivalency Is Being Claimed: | MAXXUS Powder Free Orthopaedic Latex Surgical Gloves as described in this 510(k) notification are substantially equivalent to the currently marketed MAXXUS Orthopaedic Latex Surgical Gloves. The manufacturing differences between the two products consist of additional steps needed to render the gloves powder free. |
| Description of the Device: | MAXXUS Powder Free Orthopaedic Latex Surgical Gloves meet the description of Rubber Surgical Gloves as described in American Society for Testing Materials (ASTM D 3577-91) as Type 1 gloves compounded primarily from rubber latex. They are brown in color and are non-powdered. They are packaged sterile in pairs in sizes 5-1/2 through 9. |

* Trademark

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# MAXXUS® POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES
## Page 2 of 2

| Intended Use of the Device: | MAXXUS Powder Free Orthopaedic Latex Surgical Gloves are intended to protect the wearer from liquids such as body fluids and blood, as well as to protect surgical wounds or sterile fields from microbiological contamination from the wearer. |
| --- | --- |
| Summary of Technological Characteristics Compared to the Predicate Device: | The current notification describes minor modifications to the manufacturing process which allow for a powder free product. |
| Brief Discussion of Nonclinical Tests: | Testing performed per ASTM D-3577-91 and 21 CFR 800.20 indicates that the product meets the requirements of these standards.
Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation or sensitization.
Final product is negative for the presence of starch using the USP iodine test. |
| Brief Discussion of Clinical Tests: | No new clinical tests were conducted under this 510(k). |
| Conclusions Drawn for the Nonclinical and Clinical Tests: | Nonclinical laboratory and animal data indicate that the powder free product meets all performance and biocompatibility requirements. |
| Other Information Deemed Necessary by FDA: | Not applicable |

* Trademark