POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP

K990210 · Mexpo Intl., Inc. · LYY · Mar 29, 1999 · General Hospital

Device Facts

• Record ID: K990210
• Device Name: POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP
• Applicant: Mexpo Intl., Inc.
• Product Code: LYY · General Hospital
• Decision Date: Mar 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

With Protein Content Labeling Claim (100 micrograms or less of total water extractable Protein per gram). A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Story

Blossom™ Powdered Latex Examination Gloves are disposable medical gloves designed for use by healthcare personnel. The gloves serve as a physical barrier to prevent cross-contamination between the wearer and the patient. They are manufactured with a specific labeling claim regarding protein content (100 micrograms or less of total water extractable protein per gram) to address potential latex sensitivity. The device is intended for over-the-counter use in clinical or similar settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powdered latex examination gloves. Features a protein content labeling claim of 100 micrograms or less of total water extractable protein per gram. Class I medical device.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier worn on the hands to prevent cross-contamination between the wearer and the patient.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 1999

Mr. Tim Thai Vice President Mexpo International, Incorporated 2671 McCone Avenue ਰੇ 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 6 6 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 5 6 5 6 6 5 6 6 5 6 6 5 6 6 Hayward, California

Re : K990210

Blossom™ Powdered Latex Examination Gloves Trade Name: with Protein Content Labeling Claim (100 micrograms or less) Requlatory Class: I Product Code: LYY January 19, 1999 Dated: January 21, 1999 Received:

Dear Mr. Thai:

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 requlations affecting your device can be found in the Code of Federal Requlations, 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 General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action.

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Page 2 - Mr. Thai

through 542 of the Act for devices under the Electronic enrough Siz on 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 deborizoof substantial equivalence of your device to a legally marketed predicate device results in a classification for your marice 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 qeneral 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/dsmamai.n.html".

Sincerely yours,

Timothy A. Ulatowski
Director

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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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.

## INDICATIONS FOR USE

| Applicant: | Mexpo International Inc. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | |
| Device Name: | BLOSSOM™ Powdered Latex Examination Gloves |
| Indications For Use: | With Protein Content Labeling Claim (100 micrograms or less of total water extractable Protein per gram). A medical glove is worn on the hand of health care and |

similar personnel to prevent contamination between health care personnel and the patient.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Qliss S. Lain

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter X

(Optional Format 1-2-96)

* For a new submission, do NOT fill in the 510(k) number blank.