COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K992171 · Allegiance Healthcare Corp. · KGO · Sep 14, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992171
• Device Name: COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
• Applicant: Allegiance Healthcare Corp.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

Coated Sterile Latex 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

Coated Sterile Latex Powder-Free Surgical Gloves; natural rubber latex formulation with nitrile coating; sterile; powder-free. Used by operating room personnel in hospitals/healthcare facilities during invasive and non-invasive medical procedures. Primary function: barrier protection for surgical wounds against contamination. Device provides physical protection; no electronic or algorithmic components.

Clinical Evidence

Bench testing only. Testing included systemic toxicity, intracutaneous reactivity, and Guinea Pig Maximization (no toxic/irritant reactions). Physical testing confirmed compliance with ASTM D3577-99 for tensile strength/elongation and 21 CFR §800.20 for barrier defects (AQL 2.5). Residual powder levels verified per ASTM D6124-97 (< 4 mg/glove).

Technological Characteristics

Natural rubber latex with nitrile coating. Sterile, powder-free. Meets ASTM D3577-99 (tensile strength/elongation) and ASTM D6124-97 (residual powder). Barrier integrity meets 21 CFR §800.20 (AQL 2.5).

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

• Ultrafree Sterile Latex Powder-Free Surgical Gloves

Submission Summary (Full Text)

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# 队99217/

### XIV. SUMMARY OF SAFETY AND EFFECTIVENESS

## Allegiance

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS COATED STERILE LATEX 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: | 6/16/99 |
| Product Trade Name: | Undetermined |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgeon's |
| Predicate Devices: | Ultrafree Sterile Latex Powder-Free Surgical Gloves |
| Description: | Coated Sterile Latex Powder-free Surgical gloves are formulated<br>using natural rubber latex and are coated with a nitrile coating.<br>These are offered powder-free and sterile. |
| Intended Use: | Coated Sterile Latex 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. |

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| Substantial Equivalence: | Coated Sterile Latex Powder-Free Surgical Gloves are substantially equivalent to Ultrafree Sterile Latex Powder-Free Surgical Gloves in that they provide the following characteristics:<br>- same intended use<br>- same sizes, configuration, packaging<br>- both made of natural rubber latex<br>- same tensile strength and thickness profiles |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Testing: | |
| Test | Result |
| Systemic Toxicity | Gloves do not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | Gloves show no reactivity. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Ultimate Elongation<br>& Tensile Strength | Gloves meet or exceed requirements for rubber surgical gloves per ASTM D3577-99. |
| Barrier Defects | Gloves exceed requirements per 21 CFR<br>§800.20, AQL = 2.5. |
| Data/Test Method | 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 4 mg of residual powder per glove. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the words "Public Health Service". The text is in a bold, sans-serif font. The words are arranged on a single line.

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SED 1 4 1999

Ms. Erica Sethi Manager, Regulatory Affairs Alleqiance Healthcare Corporation 1500 Waukeqan Road McGaw Park, Illinois 60085

Re : K992171 Coated Sterile Latex Powder-Free Surgical Trade Name: Gloves with Protein Content Labeling Claim (50 micrograms or less) Requlatory Class: · 4 · Product Code: KGO Dated: August 18, 1999 Received: August 19, 1999

Dear Ms. Sethi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst 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 regulations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements 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

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Page 2 -Ms. Sethi

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 described in your sia equivalence of your device to a legally marketed predicate device results in a classification for your marketed production of mits 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 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 che Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to che regulation chercica) Missions information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timbthy 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: | |
| Device Name: | Coated Sterile Latex Powder-Free Surgical Gloves<br>With Protein Content Labeling Claim (50 micrograms or less) |
| Indications For Use: | These gloves are intended for use in environments within hospitals<br>and other healthcare facilities. The gloves are appropriate for use during<br>invasive as well as non-invasive medical procedures requiring sterility.<br>They are intended to be worn by operating room personnel to protect a<br>surgical wound from contamination. |

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|------------------------------------------|-----------------------------------------------------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | or Over-The Counter Use <span style="text-align:right;">✓</span> |
| | (Division Sign-Off)<br>Division of Dental, Infection Control,<br>and General Hospital Devices |
| 510(k) Number | K992171 |