POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS)

K994162 · Allegiance Healthcare Corp. · LYY · Feb 9, 2000 · General Hospital

Device Facts

• Record ID: K994162
• Device Name: POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS)
• Applicant: Allegiance Healthcare Corp.
• Product Code: LYY · General Hospital
• Decision Date: Feb 9, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner. These Dental Latex Examination Gloves are intended specifically for Dentistry and will be worn during dental cleaning, filling and examination in non-sterile environments within hospitals and other healthcare facilities.

Device Story

Dental Latex Examination Gloves are non-sterile, natural rubber latex gloves designed for use in dental settings. They function as a physical barrier to prevent cross-contamination between dental clinicians and patients during routine procedures like cleanings and fillings. The device is used in hospitals and healthcare facilities by dental staff. The gloves are manufactured to meet specific tensile strength and barrier defect standards, ensuring integrity during clinical use. By providing a protective layer, the gloves reduce the risk of pathogen transmission, supporting infection control protocols in the dental environment.

Clinical Evidence

Bench testing only. Testing included primary skin irritation, systemic toxicity, intracutaneous reactivity, and hemocompatibility, all showing no adverse reactions. Physical performance met or exceeded ASTM D3578-99 requirements for ultimate elongation and tensile strength. Barrier integrity met 21 CFR §800.20 requirements (AQL = 4.0).

Technological Characteristics

Material: Natural rubber latex. Form factor: Disposable examination glove. Standards: ASTM D3578-99 (tensile strength/elongation), 21 CFR §800.20 (barrier defects). Non-sterile. No software or electronic components.

Indications for Use

Indicated for use by dental healthcare professionals as a disposable barrier on hands or fingers to prevent cross-contamination between patient and examiner during dental procedures including cleaning, filling, and examination.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Dental Latex Examination Gloves

Submission Summary (Full Text)

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#### 9 2000 FEB

## XIV. SUMMARY OF SAFETY AND EFFECTIVENESS

# Allegiance

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DENTAL LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM

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

Regulatory Affairs Contact: Erica Sethi Allegiance Healthcare Corporation 1500 Waukegan Road, Bldg. K McGaw Park, IL 60085

Telephone: [phone]

Date Summary Prepared: November 22, 1999

Product Trade Name: Dental Latex Examination Gloves With Protein Labeling Claim

Common Name: Examination Glove

Classification: Patient Examination Glove

Predicate Devices: Dental Latex Examination Gloves

Description: Dental Latex Examination Gloves are formulated using natural rubber latex and offered non-sterile.

Intended Use: These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner. These Dental Latex Examination Gloves are intended specifically for Dentistry and will be worn during dental cleaning, filling and examination in non-sterile environments within hospitals and other healthcare facilities.

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Substantial Equivalence: The Dental Latex Examination Gloves With Protein Labeling Claim are substantially equivalent to Dental Latex Examination Gloves in that they provide the following characteristics:

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

#### Summary of Testing:

| Test | Result |
|-------------------------------------------|----------------------------------------------------------------------------------------|
| Primary Skin Irritation | Gloves do not display any potential for irritation. |
| Systemic Toxicity | Gloves do not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | Gloves show no reactivity. |
| Hemocompatibility | Gloves are hemocompatible exhibiting no lysis. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Ultimate Elongation<br>& Tensile Strength | Gloves meet or exceed requirements for rubber examination gloves<br>per ASTM D3578-99. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR<br>\$800.20, AQL = 4.0. |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or a person's profile. The symbol is composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2000 FEB

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

K994162 Re : Powdered Dental Latex Powdered Examination Trade Name: Gloves, With Protein Content Labeling Claim (75 Micrograms Or Less) Requlatory Class: I Product Code: LYY Dated: January 24, 2000 Received: January 27, 2000

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 The general controls provisions of the Act 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 (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 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Ms. Sethi

the Federal Register. Please note: this response to your premarket notification submission does not affect any prematice nocerreder on under sections 531 through 542 of obligation you magno mars the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as fire is do " "I wour 510 k) premarket notification." The FDA described in your sie wir privalence of your device to a legally finding of bubbeaneral squresults in a classification for your marketed produces with 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 regaradiagnostic 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 orrece or compiled, "Misbranding by reference to ene regulation one one (21 CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your of Small Manufacturers Assistance obcarned from eno mumber [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a bold, italicized font. To the left of the word is a graphic of a cluster of dots arranged in a square pattern. The word is written in black, and the background is white.

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:

POWDERED

A Dental Latex Examination Gloves With Protein Labeling Claim Device Name: (75 micrograms or less)

Indications For Use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

(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 /

Ohm S. Lim

(Division Sign-Off) Division of Dental, Infection C and General Hospital 5 1 O(k) Number .

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