PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE

K050152 · Dipped Products (Thailand), Ltd. · LYY · Feb 7, 2005 · General Hospital

Device Facts

• Record ID: K050152
• Device Name: PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE
• Applicant: Dipped Products (Thailand), Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Feb 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Indications for Use

A powder-free patient examination glove is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Device Story

Palm-Pro and Palm-Pro Premium are non-sterile, disposable, powder-free natural rubber latex examination gloves. Used by healthcare professionals in clinical settings to provide a protective barrier against infectious materials and contaminants. Gloves are worn on the hand or fingers. Device benefits include barrier protection while maintaining low protein content (≤ 50μg/g) to reduce potential for latex sensitivity. No complex processing or electronic components involved.

Clinical Evidence

No clinical data required; substantial equivalence supported by bench testing including ASTM D-3578-01a compliance for physical properties and dimensions, ASTM D-6124-01 for powder content, and ASTM D-5172-95 for protein levels.

Technological Characteristics

Natural rubber latex examination gloves; powder-free; polymer coated. Meets ASTM D-3578-01a and FDA 21 CFR 800.20 standards. Protein content ≤ 50μg/g. Biocompatibility confirmed via primary skin irritation and dermal sensitization testing.

Indications for Use

Indicated for use as a disposable, non-sterile, powder-free natural rubber latex barrier worn on the hand or fingers by healthcare personnel to protect against infectious materials and 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.

Predicate Devices

• Kimberly Clark Safeskin product (K012815)
• Ansell Protective Products Accutech Ambi 91-109 product (K913766)

Submission Summary (Full Text)

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FEB - 7 2005

## 510(k) Summary

510(k) # K050152

| Manufacturer's Name: | Dipped Products (Thailand) Limited |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Facility Address: | 400 Deans Road<br>Colombo 10<br>Sri Lanka |
| Telephone number: | [phone] |
| Facsimile Number: | [phone] |
| Contact name: | Ian Gordon, VP<br>Emergo Group, Inc.<br>Clearwater, FL 33761 USA<br>727-797-4727 phone<br>727-797-4757 FAX |
| Date of Preparation: | January 14, 2005 |
| Proposed Device: | Palm-Pro and Palm-Pro Premium<br>Powder-Free Latex Examination Gloves With Protein Content<br>Labeling Claim (50 Micrograms or Less) |
| Predicate Device: | Kimberly Clark Safeskin product, K012815<br>Ansell Protective Products Accutech Ambi 91-109 product<br>K913766 |

# Description of Device:

A non-sterile, disposable, patient examination glove made of natural rubber latex, powder-free, with or without polymer coating.

The proposed and the predicate devices are Class I patient examination gloves, 80L Y Y, powder-frec, that meets all the requirements of ASTM standard D-3578 and FDA 21 CFR 800.20. .

A powder-free patient examination glove is a disposable device Intended Use: made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

| Characteristics | Standards | Device Performance | SE to Predicate |
|-----------------------|-------------------------------------------------|---------------------------------------------------|-----------------|
| Dimensions | ASTM D 3578-01a | Meets | Same |
| Physical Properties | ASTM D 3578-01a | Meets | Same |
| Freedom from pinholes | ASTM D-3578-01a<br>FDA 21 CFR 800.20 | Meets | Same |
| Powder-Free | ASTM D 6124-01 | < 2mg/glove | Same |
| Protein level | ASTM D-5172-95 | < 50μg/g | Same |
| Biocompatibility | Primary Skin Irritation<br>Dermal Sensitization | Not a skin irritation<br>Not a contact sensitizer | Same |

### Summary of Technological Characteristics:

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### Page 2 of 2 510(k) SUMMARY

# Substantial Equivalence - Non-clinical Performance Data.

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

No Clinical Performance Data required.

### Conclusion

Based on the non-clinical performance data that demonstrates the proposed device is as safe and as effective, and performs as well as or better than the legally marketed device identified herein, it can be concluded that the proposed Powder-Free Latex Examination Gloves are substantially equivalent to currently marketed devices.

end

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 7 2005

Dipped Products (Thailand) Limited C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K050152

R030152
Trade/Device Name: Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 20, 2005 Received: January 24, 2005

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becareermined the device is substantially equivalent (for the relevelect above and nave acterinelosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmiseree prior to that have been reclassified in accordance with the provisions of Amendinents, of to dovices that have of the equire approval of a premarket the rederal Pood, Drug, und Ocometive , therefore, market the device, subject to the general approval application (1 Miry) . The general controls provisions of the Act include confors provisions of the Fist - Free Jisting 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 (FMA), it may be subject to back adon't begulations, Title 21, Parts 800 to 898. In your device can be found in the Cours in concerning your device in the Federal Register.

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Page 2 - Mr. Lehtonen

Please be advised that FDA's issuance of a substantial equivalence determination does not Flease be auvrsou that 1 Dr. o teemination that your device complies with other requirements Incall that 127 mas made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal statutes and rightenents, including, but not limited to: registration r ou must comply with and and the new (21 CFR Part 801); good manufacturing practice and alla listing (21 CF R Furt 087), labelity systems (QS) regulation (21 CFR Part 820); and if requirenchts as set forth in the quality sign 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) This letter will anow you to begal finding of substantial equivalence of your device to a premiter notification. - The FD Primatis 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), If you desire specific advise to: Joan as [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 inay obtain other general mierers, International and Consumer Assistance at its toll-free Dribber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clair Lier, 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 Name: Dipped Products Limited 510(k) Number (if known):

Device Name:

Common or usual name: powder free latex patient examination gloves with protein content labeling claim (50 micrograms or less)

Trade or Proprietary Name: Model/Catalog Number:

Palm Pro Premium , 6PF1 (6PF1A24E)

Palm Pro Trade or Proprietary Name : 6PF2 (6PF2A24E) Model/Catalog Number:

Indications for Use: A powder-free patient examination glove is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or linger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Over-The-Counter Use X Prescription Use AND/OR ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D) (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)

Suette Michael and.

Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Dev

510(k) Number: K 030132