FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE

K031020 · Pt. Mandiri Inti Buana · LYY · May 21, 2003 · General Hospital

Device Facts

• Record ID: K031020
• Device Name: FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
• Applicant: Pt. Mandiri Inti Buana
• Product Code: LYY · General Hospital
• Decision Date: May 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Latex Examination Glove, Powdered, Non Sterite ia 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 gloves; worn on examiner's hand or finger; intended to prevent cross-contamination between patient and examiner during medical procedures. Device is non-sterile and powdered. Used in clinical settings by healthcare providers. Provides physical barrier protection.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including physical property assessment, pinhole leak testing per FDA 21 CFR 800.20, and biocompatibility studies.

Technological Characteristics

Material: Natural rubber latex. Form factor: Powdered, non-sterile examination glove. Standards: ASTM D 3578-01a2 (dimensions, physical properties, pinholes), ASTM D 6124-01 (powder amount). Biocompatibility: Passes primary skin irritation and dermal sensitization tests.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Made of natural rubber latex.

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)

{0}------------------------------------------------

# PT. Mandiri Inti Buana

### MAY 21 2003

### Jalan Listrik No, 6 Medan-20112 INDONESIA

- 62-81-45860
- 62-81-46860

# 510 (K) SUMMAR

#### 1.0 Submitter :

| Name | PT. Mandiri Inti Buana |
|-----------|----------------------------|
| Address | Jl. Listrik No.6 |
| | Medan - Indonesia, 200112. |
| Phone No. | [phone] |
| Fax No. | [phone] |

Date of Summary Prepared :

### Contact Person :

2.0

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

#### Name of the device : 3.0

| Trade Name | 1). Flexiskin, and<br>2). Multiple or Customers' Trade Name |
|---------------------|-------------------------------------------------------------|
| Device Name | : Latex Examination Gloves, Powdered, Non-Sterile |
| Common Name | : Examination Gloves |
| Classification Name | : Patient Examination Gloves (Class 1) |

### ldentification of The Legally Marketed Device : 4.0

Class I patient examination gloves, 80LYY, powdered, that meets all the requirements of ASTM standard D 3578 - 01a82 and FDA 1000 ml Water Leak Test.

### Description of The Device : 5.0

The Latex Examination Gloves, Powdered, Non Sterile meets all the reguirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Tost.

#### Intended Use of the Device : 6.0

The Latex Examination Glove, Powdered, Non Sterite ia a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

{1}------------------------------------------------

## PT. Mandiri Inti Buana

### Jalan Liatrik No. 6 Medan-20112 INDONESIA

# KO3/020/51

[phone] Tel + 62-81-4566806 883

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

The Latex Examination Gloves, Powdered, Non Sterile are summanized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE |
|-----------------------|------------------------------------|----------------------------------------|
| Dimensions | D 3578 - 01a2 | Meets |
| Physical Properties | D 3578 - 01a2 | Meets |
| Freedom from Pinholes | D 3578 - 01a2<br>FDA 21 CFR 800.20 | Meets |
| Powder Amount | D 3578 - 01a2<br>D 6124 - 01 | < 10 mg/dm²/ 39.15 mg/glove |
| Biocompatability | Primary Skin Irritation in Rabbits | Passes<br>(No primary skin irritation) |
| | Dermal Sensitization | Passes<br>(No contact sensitizer) |

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

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

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

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

#### Conclusion 10.0

It can be concluded that the Latex Examination Gloves, Powdered, Non Sterlie 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.

Page 2 of 2

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by flowing lines that create a sense of unity and movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2003

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

Re: K031020

Trade/Device Name: Latex Examination Gloves, Powdered, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 23, 2003 Received: April 28, 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 Riens

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] Fax [phone]

### INDICATIONS FOR USE

Applicant

: PT. Mandiri Inti Buana

510(k) Number (if known)

Device Name

: LATEX EXAMINATION GLOVES, POWDERED, NON STERILE

Indications For Use:

Latex Examination Gloves, Powdered, Non-Sterile 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<br>(Per 21 CFR 801.109) | |
|------------------------------------------|--|
| OR Over-The-Counter | |

Chis S. Lin

510(k) Numbe

sthesionav General Hr