POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE

K052273 · Pt Mahakarya Inti Buana · LYY · Sep 30, 2005 · General Hospital

Device Facts

• Record ID: K052273
• Device Name: POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
• Applicant: Pt Mahakarya Inti Buana
• Product Code: LYY · General Hospital
• Decision Date: Sep 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Olymer Examination Glove , Powder Free Non Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purpose that is worn on the examiner's hand or finger or prevent contamination between patient and examiner.

Device Story

Polymer latex examination glove; disposable; non-sterile; powder-free. Worn by clinicians on hands/fingers during examinations. Acts as a physical barrier to prevent cross-contamination between patient and examiner. Manufactured from synthetic polymer with rubber-like characteristics. Device performance verified against ASTM D 3578-01 standards for dimensions, physical properties, and pinhole resistance.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including physical property assessment, pinhole testing, powder residue analysis, protein content quantification, and biocompatibility (skin irritation and sensitization) testing per ASTM standards.

Technological Characteristics

Material: Synthetic polymer (latex). Powder-free (< 2 mg/glove). Protein content < 50 µg/g. Standards: ASTM D 3578-01 (dimensions, physical properties, pinholes), ASTM D6124-01 (powder residue), ASTM D 5712-99 (protein content). Biocompatibility: Passes primary skin irritation and dermal sensitization tests. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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.

Submission Summary (Full Text)

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# PT. MAHAKARYA INTI BUANA

Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa -- 20362 SUMUT - INDONESIA

Tiel [phone] [phone] liax

# 510 (K) SUMMARY

| 1.0 | Submitter: | | |
|-----|--------------------------|---|-----------------------------------------------------------------------------------------------|
| | Name | : | PT MAHAKARYA INTI BUANA |
| | Address | : | Jl. Sei Belumai, Desa Dalu 10 A Dusun I No. 18<br>Tanjung Morawa - 20362<br>SUMUT – INDONESIA |
| | Phone No. | : | [phone] |
| | Fax No. | : | [phone] |
| | Date of Summary Prepared | : | |

#### 2.0 Contact Person:

| Name | : | Mr. Sasitharan Nair |
|---------|---|---------------------|
| Phone | : | [phone] |
| Fax No. | : | [phone] |

SEP 3 0 2005

#### 3.0 Name or the device:

| Trade Name | 1) Senstouch and<br>2) Multiple or Customers' Trade Name |
|---------------------|------------------------------------------------------------|
| Device Name | Polymer Latex Examination Gloves, Powder Free, Non Sterile |
| Common Name | Examination Gloves |
| Classification Name | Patient Examination Gloves (Class I) |

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

Class I Examination gloves, 80 LYY, Powder Free, that meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

### 5.0 Description of The Device

The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

### 6.0 Intended Use of The Device

The Polymer Examination Glove, Powder Free, Non Sterile is a disposable device intended for medical purposes that is worn on the examincr's to prevent contamination between patient and examiner.

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# PT. MAHAKARYA INTI BUANA

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Ticl 162-61-7944880 [phone] l'ax

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

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

| CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE |
|----------------------------------|---------------------------------------|----------------------------------------|
| Dimension | D 3578 -01 ae² | Meets |
| Physical Properties | D 3578 -01 ae² | Meets |
| Freedom from Pinholes | D 3578 -01 ae²<br>FDA 21 CFR 800.20 | Meets |
| Powder Free Residue | D 3578 -01 ae²<br>D6124 - 01 | < 2 mg/glove |
| Water Soluble Protein<br>Content | D 3578 -01 ae²<br>D 5712 - 99 | < 50 µg/g |
| Biocompatibility | Primary Skin Irritation in<br>Rabbits | Passes<br>(No Primary Skin Irritation) |
| Biocompatibility | Dermal Sensitization | 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) processes.

### 10.0 Conclusion

It can be concluded that The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) will perform according to the gloves 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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Public Health Service

SEP 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sasitharan Nair TOM Managaer PT. Mahakarya Inti Buana J1. Sei Belumani, Desa Dalu 10 A Dusun No. 18, Tanjung Morawa, Sumut, INDONESIA 20362

Re: K052273

Trade/Device Name: Polymer Coated Latex Examination Glove, Powder Free, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: September 22, 2005 Received: September 26, 2005

Dear Mr. Nair:

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. Nair

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 (QS) 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 vour 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,

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

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# Indications for Use

510(k) Number (if known):

Device Name: POLYMER EXAMINATION GLOVE, POWDER FREE, NON STERILE Indications For Use: "Olymer Examination Glove , Powder Free Non Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purpose that is worn on the examiner's hand or finger or prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shail H. Murchison, MD a bules-

(Division Sign-Off) person Oigh-Old)
Division of Anesthesiology, General Hospital, Infection Control, Dental Dental Devices Page 1 of 1 510(k) Number

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