SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE

K053305 · Pt Mahakarya Inti Buana · LYY · Jun 2, 2006 · General Hospital

Device Facts

• Record ID: K053305
• Device Name: SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
• Applicant: Pt Mahakarya Inti Buana
• Product Code: LYY · General Hospital
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Disposable powdered natural rubber latex examination glove; worn by healthcare examiners to provide barrier protection against infectious materials and contaminants; prevents cross-contamination between patient and examiner. Device is non-sterile; facilitates donning via powder. Used in clinical settings; operated by healthcare personnel.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing including primary skin irritation and dermal sensitization tests in rabbits, and physical property testing per ASTM D 3578-01 ae2 and ASTM D 6124-01.

Technological Characteristics

Natural rubber latex examination glove. Meets ASTM D 3578-01 ae2 for dimensions and physical properties. Powder residue < 10 mg/dm². Water-soluble protein content < 200 µg/dm² (ASTM D 5712-99). Biocompatibility: passes primary skin irritation and dermal sensitization tests. Non-sterile.

Indications for Use

Indicated for use as a disposable natural rubber latex glove worn on the hand or fingers for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

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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Image /page/0/Picture/0 description: The image shows a stylized, black and white graphic of the letters 'MB' in a gothic or medieval-style font. The letters are bold and blocky, with sharp angles and thick strokes, giving them a somewhat imposing appearance. The overall design has a vintage or old-fashioned feel due to the font choice and the slightly rough or textured quality of the image.

1.0

## PT. MAHAKARYA INTI BUANA

JUN - 2 2006

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

Tel [phone] [phone] Fax

| | 510 (K) SUMMARY | K063305 |
|------------|-----------------------------------------------------------------------------------------|---------|
| Submitter: | | |
| Name | PT. MAHAKARYA INTI BUANA | |
| Address | Jl. Sei Belumai, Desa Dalu 10 A Dusun I No. 18 Tanjung Morawa - 20362 SUMUT – INDONESIA | |

| Phone No. | [phone] |
|--------------------------|----------------|
| Fax No. | [phone] |
| Date of Summary Prepared | |

#### 2.0 Contact Person:

| Name | : | Mr. V. Nadarajan |
|---------|---|------------------|
| Phone | : | [phone] |
| Fax No. | : | [phone] |

#### 3.0 Name or the device:

| Trade Name | 1) Senstouch and<br>2) Multiple or Customers' Trade Name |
|---------------------|----------------------------------------------------------|
| Device Name | Powdered Latex Examination Gloves, 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, LYY, Powdered, 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 Powdered Latex Examination Gloves, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm4) 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 Powdered Latex Examination Glove, Powdered, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.

Page 1 of 2

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PT. MAHAKARYA INTI BUANA

Image /page/1/Picture/1 description: The image shows a stylized, black and white graphic of the letters "MB" in a gothic or old English font. The letters are bold and have a textured appearance, giving them a slightly rough or aged look. The overall design is simple yet striking, with the letters being the primary focus.

11053305

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

Tel [phone] [phone] Fax

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

The Powdered Latex Examination Gloves, Powdered, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm2) 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 Residue | D 3578 -01 ae2<br>D6124 - 01 | < 10 mg/dm² |
| Water Soluble Protein<br>Content | D 3578 -01 ae2<br>D 5712 - 99 | < 200 µg/dm² |
| Biocompatibility | Primary Skin Irritation in<br>Rabbits | Passes |
| | Dermal Sensitization | Passes |

- 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. The samples are from the final product.
- Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0 The sample items used during the Primary Skin Irritation Test and the Dermal Sensitization Test is from the final product.

#### 10.0 Conclusion

It can be concluded that The Powdered Latex Examination Gloves, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm') 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN =2 2006

Mr. V. Nadarajan Manager, QA/RA Jalan Sei Belumai Desa Dalu 10 A Dusun 1 No. 18 Tanjung Morawa-20362 SUMUT-INDONESIA

Re: K053305

Trade/Device Name: Senstouch Powdered Latex Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: May 10, 2006 Received: May 15, 2006

Dear Mr. Nadarajan:

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. Nadarájan

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device 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 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 vours.

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

510(k) Number (if known): 《OS 3305

Device Name: . .

POWDERED LATEX EXAMINATION GLOVE, NON STERILE

Indications For Use:

A Powdered Latex Examination Glove Non Sterile is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand of finger(s) for a medical purpose to provide a barrier againts potentially insfectious material and other contaminations.

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)

Clues

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i & Anesthesiology, General Hospital,
ion Control, Dental Devices