ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES

K011721 · Allegiance Healthcare Corp. · KGO · Aug 14, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K011721
• Device Name: ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
• Applicant: Allegiance Healthcare Corp.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Aug 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

Powder-Free Sterile Synthetic 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

Esteem Sterile Polyisoprene Surgical gloves are powder-free, sterile, synthetic rubber latex gloves. Used by operating room personnel in hospitals and healthcare facilities during invasive and non-invasive medical procedures. Primary function is to provide a sterile barrier to protect surgical wounds from contamination. Device is a physical barrier; no electronic or software components.

Clinical Evidence

Bench testing only. Testing included intracutaneous reactivity and Guinea Pig Maximization (no sensitization potential). Physical testing met ASTM D3577-00 requirements for ultimate elongation and tensile strength. Barrier integrity met 21 CFR 800.20 and ASTM D3577-00 (AQL = 1.5). Residual powder levels met ASTM D6124-97 (< 2 mg/glove).

Technological Characteristics

Material: Synthetic rubber latex. Form factor: Sterile surgical glove. Standards: ASTM D3577-00 (tensile strength, elongation, barrier defects), ASTM D6124-97 (residual powder). Sterilization: Sterile. No software or electronic components.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination during invasive and non-invasive medical procedures requiring sterility in hospital and healthcare facility environments.

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 Powder-Free Sterile Synthetic Surgical Gloves

Submission Summary (Full Text)

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# AUG 1 4 2001

# XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

KO/1721

# Allegiance

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

| Regulatory Affairs Contact: Erica Sethi | Allegiance Healthcare Corporation<br>1500 Waukegan Road, MP-WM<br>McGaw Park, IL 60085 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Date Summary Prepared: | 5/25/01 |
| Product Trade Name: | Esteem Sterile Polyisoprene Surgical gloves |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgeon's |
| Predicate Devices: | Duraprene Powder-Free Sterile Synthetic Surgical Gloves |
| Description: | Powder-Free Sterile Synthetic Surgical gloves are formulated using<br>Synthetic Rubber Latex. These are offered powder-free and sterile. |
| Intended Use: | Powder-Free Sterile Synthetic 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. |

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### Substantial Equivalence:

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

- same intended use

Gloves show no irritation.

- same sizes, product features, packaging
- both made of Synthetic Rubber Latex using similar manufacturing process

Summary of Testing:

Test

### Result

Intracutaneous Reactivity

Guinea Pig Maximization

Ultimate Elongation & Tensile Strength

Barrier Defects

Data/Test Method

Gloves do not display any potential for sensitization.

Gloves exceed requirements for rubber surgical gloves per ASTM D3577-00.

Gloves exceed requirements per 21 CFR \$800.20 and ASTM D3577-00, AQL = 1.5.

Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-97-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 4 2001

Ms. Erica Sethi Manager of Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road 60085 McGaw Park, Illinois

K011721 Re : Powder-Free Sterile Synthetic Trade/Device Name: Polyisoprene Surgical Gloves Regulation Number: 878.4460 Regulatory Class: I Product Code: KGO Dated: May 4, 2001 Received: June 4, 2001

Dear Ms. Sethi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marree is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate abe beaut in on erstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to che chat have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the roading the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual provistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2 - Ms. Sethi

In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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 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,

Patricia Cuesnitoffor

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

Enclosure

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

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| Applicant: | Allegiance Healthcare Corporation |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K011721 |
| Device Name: | Powder-Free Sterile Synthetic Surgical Gloves (POLYISOPRENE) |
| Indications For Use: | These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination 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. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OL

Over-The Counter Use _

Qiu Si Lin

(Division Sign-Off) (Division of Dental, Infection Control,
Division of Dental, Infection Control, Division of Dentall Device 510(k) Number -6