SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES

K973615 · Macro Rubber Industrial, Inc. · LYY · May 20, 1998 · General Hospital

Device Facts

• Record ID: K973615
• Device Name: SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES
• Applicant: Macro Rubber Industrial, Inc.
• Product Code: LYY · General Hospital
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Powder-free latex examination gloves; ambidextrous; worn by clinicians in medical and dental settings to provide barrier protection; prevents cross-contamination between patient and examiner; supplied in 100-pack dispensers.

Clinical Evidence

Bench testing only; compliance with ASTM D 5712 and ASTM 3578-91 standards demonstrated.

Technological Characteristics

Latex material; powder-free; ambidextrous; protein content ≤ 50 micrograms; complies with ASTM D 5712 and ASTM 3578-91.

Indications for Use

Indicated for use in medical and dental communities to prevent contamination between patient and examiner.

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

• Safeskin Satin Plus Latex Examination Gloves

Submission Summary (Full Text)

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510(K) SUMMARY (as required by 807.92(c))

MAY 20 1998

K913615

Submitter of 510(k):

Regulatory & Marketing Services, Inc. (RMS) 40178 U.S. 19 North Tarpon Springs, FL 34689

813-942-3908 Phone: [phone] Fax:

Contact Person:

Ed Ransom

Date of Summary:

Trade Name:

Classification Name:

Predicate Device:

Device Description/ Comparison:

August 18, 1997

SkinGard TPF AOSSTEX TPF SensiFree Essential TPF Amerglo TPF

Latex Examination Gloves

Safeskin Satin Plus Latex Examination Gloves

Latex examination gloves - ambidextrous Comparative Chart

| | Marsin | Safeskin |
|--------------|--------------------|----------|
| ASTM D 5712 | completed | same |
| ASTM 3578-91 | Completed | same |
| Glove | Latex | same |
| Low Protein | ≤ 50 Micrograms | same |
| Intended Use | Examination | same |
| Packaging | 100 Pack dispenser | same |

Intended Use:

Intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right, and a flowing, ribbon-like element beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 20 1998

Marcon Rubber Industrial, Incorporated ·C/O Mr. Ed Ransom Regulatory & Marketing Services, Incorporated (RMS) 3234 Ella Lane New Port Richey, Florida 34655

Re : K973615 SkinGard TPF/AOSSTEX TPF/SensiFree/Essential Trade Name: TPF/Ameriglo TPF Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Tess) Regulatory Class: I Product Code: Lyy Dated: April 28, 1998 Received: April 29, 1998

Dear Mr. Ransom:

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 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), 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 (Premarket Approval), it may . be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ਼ੁ 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 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

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Page 2 - Mr. Ransom

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 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 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 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. 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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510(k) Number (if known): K973615
Device Name: Powder-Free
A Latex Examination Gloves WITH PROTEIN CONTENT LABELING
CLAIM (50 MICROGRAMS OR LESS)
Proprietary Names:
SkinGard TPF
AOSSTEX TPF
SensiFree
Essential TPF
Amerglo TPF

## Indications For Use:

The fatex examination gloves are used in both the Medical & Dental Communities, to prevent contamination between patient and examiner.

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Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

-
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devicon
\$100

and General Hospital Infect

510(k) Number

(Optional Format 1-2-96)