POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE

K070821 · Medtexx Manufacturing Sdn. Bhd. · LYY · May 10, 2007 · General Hospital

Device Facts

• Record ID: K070821
• Device Name: POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
• Applicant: Medtexx Manufacturing Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: May 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powdered Natural Rubber Latex Examination Gloves are intended for single use for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patients.

Device Story

Powdered natural rubber latex examination gloves; single-use protective barrier; worn on hands by healthcare personnel; prevents cross-contamination between clinician and patient; manufactured from natural rubber latex; natural white color; powdered finish.

Clinical Evidence

No clinical tests conducted. Non-clinical evidence includes bench testing per ASTM D 3578-05 and 21 CFR 800.20, plus animal studies (rabbit primary skin irritation and guinea pig delayed dermal contact sensitization) demonstrating no irritation or sensitization.

Technological Characteristics

Material: Natural rubber latex. Form: Powdered, natural white color. Standards: ASTM D 3578-05. Biocompatibility: Tested for skin irritation and sensitization.

Indications for Use

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

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

• Class 1 Patient Examination glove (product code 80LYY)

Submission Summary (Full Text)

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Attachment 17
K070821

## 510(k) SUMMARY

MAY 1 0 2007

## POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES

| Submitter's Name | MEDTEXX MANUFACTURING SDN. BHD. |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address | PT 4004, Kamunting Industrial Estate<br>34600 Taiping, Perak,<br>Malaysia |
| Submitter's Phone Number | 605-891 1111 / 605-891 5555 |
| Submitter's Fax Number | 605-891 1088 |
| Name of Contact Person | Ooi Loon Seng |
| Date of Preparation | |
| Name of Device | |
| Trade Name | : POWDERED NATURAL RUBBER LATEX<br>EXAMINATION GLOVES |
| Common Name | : Latex Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Legally Marketed Device to which Equivalency is<br>Being Claimed | Powdered Natural Rubber Latex Examination<br>Gloves as described in this 510 K Notification is<br>substantially equivalent to the current Class 1<br>Patient Examination glove bearing the product<br>code 80LYY ( 21 CFR 880.6250 ). It meets all the<br>current specifications listed under the ASTM<br>Specification D 3578-05, Standard Specification<br>for Rubber Examination Gloves. |
| Description of the Device | Powdered Natural Rubber Latex Examination<br>Glove is substantially equivalent to the Class 1<br>patient examination glove bearing the product<br>code 80LYY ( 21 CFR 880.6250 ). It meets all the |

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| | current specifications listed under the ASTM<br>Specification D-3578-05, Standard Specification<br>for Rubber Examination Gloves. They are made<br>from natural rubber latex. They are natural white<br>in color and are powdered. |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of the Device | Powdered Natural Rubber Latex Examination<br>Gloves are intended for single use for medical<br>purposes that is worn on the hand of health care<br>and similar personnel to prevent contamination<br>between the health care personnel and the<br>patients. |
| Summary of Technological Characteristic<br>Compared to the Predicate Device | There is no different technological characteristic.<br>Gloves are made from natural rubber latex<br>compound and the initial products are powdered<br>natural rubber latex examination gloves. |
| Brief Description of Non-Clinical Tests | Testing performed per ASTM<br>D 3578-05,<br>Standard Specification for Rubber Examination<br>Gloves and 21 CFR 800.20. Gloves meet all the<br>current ASTM D 3578-05.<br>Primary skin irritation testing in the rabbit and<br>delayed dermal contact sensitization study in the<br>guinea pigs indicate no irritation or sensitization. |
| Brief description of Clinical Tests | No new clinical tests were conducted under this<br>510(k). |
| Conclusions Drawn from the Non-Clinical and<br>Clinical Tests | Non-Clinical laboratory and animal test data<br>indicate that the powdered product meets all<br>performance and biocompatibility requirements. |
| Other Information Deemed Necessary by FDA | Not Applicable |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 0 2007

Mdm. Ooi Loon Seng Regulatory Affairs Manager Medtexx Manufacturing Sdn. Bhd. PT 4004 Kamunting Industrial Estate, Taiping Kamunting Perak, 34600 MALAYSIA

Re: K070821

Trade/Device Name: Powdered Natural Rubber Latex Examination Gloves (Protein Label Claim) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: March 23, 2007 Received: March 26, 2006

Dear Mdm. Seng:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Suver Kune

Chin Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

Applicant

MEDTEXX MANUFACTURING SDN. BHD. PT 4004, Kamunting Industrial Estate, 34600 Kamunting , Perak, Malaysia.

510(k) Number (if known)

070821

Device Name

POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)

Indications For Use

Powdered Natural Rubber Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Concurrence of CDRH Office of Device Evaluation (ODE )

Prescription Use Per 21 CFR 801.109 OR Over-The-Counter

Shule V. Murphy Ko

Anestiiesiology, General Hospal,
Jon Control, Demal Devices
ck) Number: K/0 821