FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE

K031754 · Pt. Mandiri Inti Buana · LYY · Jun 30, 2003 · General Hospital

Device Facts

• Record ID: K031754
• Device Name: FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE
• Applicant: Pt. Mandiri Inti Buana
• Product Code: LYY · General Hospital
• Decision Date: Jun 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Latex Examination Glove, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable natural rubber latex examination glove; worn on examiner's hand or finger; acts as physical barrier to prevent cross-contamination between patient and examiner; used in medical settings; non-sterile; powder-free; contains ≤ 50µg/g water-extractable protein.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including ASTM D 3578-01ae2 (dimensions, physical properties, pinholes), ASTM D 6124-01 (powder residue), ASTM D 5712-99 (protein content), and biocompatibility testing (primary skin irritation and dermal sensitization).

Technological Characteristics

Natural rubber latex; powder-free; non-sterile. Meets ASTM D 3578-01ae2, ASTM D 6124-01, and ASTM D 5712-99. Protein content < 50µg/g; powder residue < 2 mg/glove. Biocompatible (passes primary skin irritation and dermal sensitization).

Indications for Use

Indicated for use as a disposable, non-sterile natural rubber latex glove worn on the examiner's hand or finger to prevent cross-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.

Submission Summary (Full Text)

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# PT. Mandiri Inti Buana

### JUN 3 0 2003

Jalan Listrik No. 6 Medan-20112 INDONESIA

[phone] Tel [phone] Fax

### 510 (K) SUMMARY

4031754

#### 1.0 Submitter :

| Name | : PT. Mandiri Inti Buana |
|-----------|--------------------------------------------------|
| Address | : Jl. Listrik No. 6<br>Medan - INDONESIA, 20112. |
| Phone No. | : [phone] |
| Fax No. | : [phone] |

Date of Summary Prepared :

#### 2.0 Contact Person :

| Name | : Mr. Ng Poy Sir |
|-----------|------------------|
| Phone No. | : [phone] |
| Fax No. | : [phone] |

#### 3.0 Name of the device :

| Trade Name | 1). | Flexiskin, and |
|---------------------|-----|------------------------------------------------------------------------------------------------------------------------------------|
| | 2). | Multiple or Customers' Trade Name |
| Device Name | : | Powder Free Latex Examination Gloves, Non-Sterile<br>Contains 50 micrograms or less of Total Water Extractable Protein per<br>gram |
| Common Name | : | Examination Gloves |
| Classification Name | : | Patient Examination Gloves (Class I) |

#### 4.0 ldentification of The Legally Marketed Device :

Class I patient examination gloves, 80LYY, powder free, that meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.

#### 5.0 Description of The Device :

The Powder Free Latex Examination Gloves, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a 22 and FDA 1000 ml Water Leak Test.

#### 6.0 Intended Use of the Device :

.

The Powder Free Latex Examination Glove, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

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## PT. Mandiri Inti Buana

[phone] Tel [phone] Fax

### Summary of The Technological Characteristics of The Device : 7.0

The Powder Free Latex Examination Gloves, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE |
|-------------------------------|---------------------------------------------------------------|-----------------------------------------------------------------------------|
| Dimensions | D 3578 - 01ae2 | Meets |
| Physical Properties | D 3578 - 01ae2 | Meets |
| Freedom from Pinholes | D 3578 - 01ae2<br>FDA 21 CFR 800.20 | Meets |
| Powder Residue | D 3578 - 01ae2<br>D 6124 - 01 | < 2 mg/glove |
| Water Soluble Protein Content | D 3578 - 01ae2<br>D 5712 - 99 | < 50µg/gram |
| Biocompatability | Primary Skin Irritation in<br>Rabbits<br>Dermal Sensitization | Passes<br>(No primary skin irritation)<br>Passes<br>(No contact sensitizer) |

#### 8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

#### 9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

#### 10.0 Conclusion

It can be concluded that the Powder Free Latex Examination Gloves, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) will perform according to the glove performance standards referenced in Section (7) above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three lines representing the head, body, and legs.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2003

Mr. Ng Poy Sin Director PT. Mandiri Inti Buana Jl. Listrik No. 6 Medan, INDONESIA 20112

Re: K031754

Trade/Device Name: Powder Free Latex Examination Gloves, Non-Sterile (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: June 20, 2003 Received: June 23, 2003

Dear Mr. Sin:

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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Page 2 - Mr. Sin

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/dsma/dsmamain.html

Sincerely vours.

Susan Runny

Susan Runner, DDS, MA Interim 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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### PT. Mandiri Inti Buana

Jalan Listrik No. 6 Medan-20112 INDONESIA

Tel [phone] [phone] Fax

### INDICATIONS FOR USE

| Applicant | : PT. Mandiri Inti Buana |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | : K031754 |
| Device Name | : POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE. (Contains 50 micrograms or less of Total Water Extractable Protein per gram) |

Indications For Use:

..

Powder Free Latex Examination Gloves, Non-Sterile (Contains 50 micrograms or less of Water Extractable Protein per gram) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|---------------------------------------------------------------------------------|---------|
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K031754 |

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