DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM

K013302 · Allegiance Healthcare Corp. · KGO · Dec 17, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013302
• Device Name: DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM
• Applicant: Allegiance Healthcare Corp.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Dec 17, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

Duraprene Sterile Synthetic Powder-Free Surgical Gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive 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

Duraprene Sterile Synthetic Powder-Free Surgical Gloves are sterile, neoprene-based gloves with a nitrile coating. Designed for use by operating room personnel in hospitals and healthcare facilities during invasive and non-invasive procedures. The gloves act as a physical barrier to protect surgical wounds from contamination. They are provided sterile and powder-free to minimize potential for irritation or reactivity.

Clinical Evidence

Bench testing only. Testing included intracutaneous reactivity (no reactivity), Guinea Pig Maximization (no irritation potential), barrier defect testing per 21 CFR §800.20 and ASTM D3577-00 (AQL = 1.5), and residual powder testing per ASTM D6124-00 (results < 2 mg per glove).

Technological Characteristics

Neoprene-based surgical gloves with nitrile coating. Sterile, powder-free. Complies with ASTM D3577-00 for barrier properties and ASTM D6124-00 for residual powder levels.

Indications for Use

Indicated for use by operating room personnel in hospitals and healthcare facilities during invasive and non-invasive medical procedures requiring sterility 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

• Duraprene Sterile Synthetic Powder-Free Surgical Gloves (K013302)

Submission Summary (Full Text)

{0}------------------------------------------------

### DEC 1 7 2001

## XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

# Allegiance

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

| Manufacturer: | Allegiance Healthcare Sdn. Bhd.<br>Plot 87, Kampung Jawa<br>11900 Bayan Lepas<br>Penang, West Malaysia |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: Erica Sethi | Allegiance Healthcare Corporation<br>1500 Waukegan Road, MP-WM<br>McGaw Park, IL 60085 |
| Telephone: | [phone] |
| Date Summary Prepared: | 9/17/01 |
| Product Trade Name: | Duraprene Sterile Synthetic Powder-Free Surgical Gloves |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgeon's |
| Predicate Devices: | Duraprene Sterile Synthetic Powder-Free Surgical Gloves |
| Description:<br>formulated | Duraprene Sterile Synthetic Powder-Free Surgical gloves are<br>using neoprene and are coated with a nitrile coating.<br>These are offered powder-free and sterile. |
| Intended Use: | Duraprene Sterile Synthetic Powder-Free Surgical Gloves are<br>intended for use in environments within hospitals and other<br>healthcare facilities. The gloves are appropriate for use during<br>invasive and non-invasive medical procedures requiring sterility.<br>They are intended to be worn by operating room personnel to<br>protect a surgical wound from contamination. |

ાર

{1}------------------------------------------------

KO1 330Z

Page 2

#### Substantial Equivalence:

Duraprene Sterile Synthetic Powder-Free Surgical Gloves are substantially equivalent to currently marketed Duraprene Sterile Powder-Free Surgical Gloves in that they provide the following characteristics:

- same intended use
- same sizes, configuration, packaging
- both made of neoprene

Summary of Testing:

| Test | Result |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intracutaneous Reactivity | Gloves show no reactivity. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Barrier Defects | Gloves exceed requirements per 21 CFR<br>§800.20 and ASTM D3577-00, AQL = 1.5. |
| Standard | ASTM D 3577-00 |
| Data/Test Method | Gloves meet powder level requirements for “Powder Free”<br>designation using ASTM Standard D6124-00-Standard test method<br>for residual powder on medical gloves. Results generated values<br>below 2 mg of residual powder per glove. |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### DEC 1 7 2001

C/O Ms. Erica Sethi Regulatory Affairs Manager Allegiance Healthcare Corporation Quality & Regulatory Affairs Division 1500 Waukegan Road, Bldg. WM McGraw Park, Illinois 60085

Re: K013302

Trade/Device Name: Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for use with Chemotherapy Drugs Labeling Claim Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: September 17, 2001 Received: October 3, 2001

Dear Ms. Sethi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

Allegiance

Allegiance Healdicare Corpοταθο
1500 Waukegan Road
McGaw Park, Illinois 60085-6787
847.473.1500
FAX: [phone]

Page 1 of 1

Applicant: Allegiance Healthcare Corporation

510(k) Number: KO13302

DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH Device Name: TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM.

Indications For Use: These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Or

Over-The Counter Use

Qhis S. Lin

IDivision Sign-Off) Division of Dental, Infection Control, and General Hospital Device : 90(k) Number _ 6