POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)

K061551 · Medipure Corporation (M) Sdn. Bhd. · LYY · Aug 24, 2006 · General Hospital

Device Facts

• Record ID: K061551
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)
• Applicant: Medipure Corporation (M) Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Aug 24, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Latex Examination Glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on hands or finger(s) for medical purposes to provide a barrier.against potentially infectious materials and other contaminants.

Device Story

Disposable natural rubber latex examination gloves; available in natural or blue color; features protein content labeling claim (≤50 µg/g). Used in clinical settings by healthcare personnel to provide a barrier against infectious materials and contaminants. Device functions as a physical barrier; no electronic or mechanical components. Performance verified through bench testing against ASTM standards for dimensions, tensile strength, pinhole resistance, and biocompatibility.

Clinical Evidence

Bench testing only. Testing included physical dimensions (palm width, length, thickness), tensile strength (unaged/aged), pinhole resistance (AQL 2.5/4.0), powder residual, protein content (ASTM D5712), and biocompatibility (primary skin irritation, dermal sensitization). All results met ASTM D3578 standards.

Technological Characteristics

Natural rubber latex examination gloves. Compliant with ASTM D3578, ASTM D6124, and ASTM D5712. Features include optional color additives and protein content labeling (≤50 µg/g). Biocompatibility confirmed via 16 CFR Part 1500 and Buehler method. Non-sterile, disposable.

Indications for Use

Indicated for use as a disposable, natural rubber latex barrier worn on hands 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

• Latex Patient Examination Gloves, Powder Free (K924356)

Submission Summary (Full Text)

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K061551

# AUG 2 4 2006

# SPECIAL 510(k) SUMMARY

#### 1.0 Modified Device Identification:

| Trade Name | 1) Safety + Comfort, and |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------|
| | 2) Multiple or Customers' Trade Name |
| Device Name | : Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 Micrograms or Less) |
| Common Name | : Examination Gloves |
| Classification Name | : Patient Examination Gloves (per 21 CFR 880.6251) |

#### 2.0 Submitter:

| Name | : Medipure Corporation (M) Sdn Bhd |
|--------------------|----------------------------------------------------------------------------------------------|
| Address | : Lot 12, Medan Tasek, Tasek Industrial Estate, 31400 Ipoh. Perak<br>Darul Ridzuan. MALAYSIA |
| Phone # | : [phone] |
| Fax # | : [phone] |
| FDA Registration # | : 8041177 |
| Device Listing # | : A722779 |

Date of Summary Prepared: May 24, 2006

#### 3.0 Contact Person:

| Name | : Mr. Terence Lim Sin Kooi |
|---------|----------------------------|
| Phone # | : [phone] |
| Fax # | : [phone] |

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

Class I powder free natural rubber latex examination gloves, 80LYY meets all the requirements of ASTM standard D 3578 - 05 and FDA 21 CFR 800.20.

#### 5.0 Predicate Device Information:

| Unmodified Device Name | : Latex Patient Examination Gloves, Powder Free |
|------------------------|-------------------------------------------------|
| Cleared 510(k) | : K924356 |
| Date Approved | : February 3, 1994 |

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#### 6.0 Description of Device Modification:

The Powder Free Latex Examination Gloves. Natural or Blue Colour and with Protein Content Labeling Claim is equivalent to the exiting model, i.e. Latex Patient Examination Gloves. Powder Free which had submitted and cleared under 510(k) number K924356.

The differences in this submission are:

- With or without colour additive upon customers` preference or request. a)
- With protein content labeling claim, i.e. "This latex glove contains 50 micrograms or b) less of total water extractable protein per gram``.

All the above options will be subjected to design controls process, whereby risk assessment will be conducted to identify the potential hazards and estimate the risks of colour changed (Refer to Section 5 – Design Control Activities for the modified Device).

The modification of device does not affect the intended use of the device as well as it does not affect its safety and effectiveness.

#### 7.0 Intended Use of the Device:

The Powder Free Latex Examination Glove, Natural or Blue Colour and with Protein Content Labeling Claim is a disposable device made of natural rubber latex and is intended to be worn on hands to provide barrier against potentially infectious materials and other contaminants on medical purposes.

The indication for use and proposed labeling for the device are illustrated in sections 3 & 4.

#### 8.0 Device Description and Comparison:

Access - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

The device description and comparison between unmodified and modified device, i.e. Powder Free Latex Examination Gloves. Natural or Blue Colour and with Protein Content Labeling Claim are as follows.

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| T | ab | 0 | |
|---|----|---|-----|
| | | ﻟ | 1 |
| | | | *** |

| | Device Name | |
|------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| | Unmodified device | Modified Device |
| 510 (K) Number | K924356 | K061551 |
| Device Listing Number | A722779 | A722779 |
| Proprietary Name | Multiple or Customers'<br>Trade Name | Safety + Comfort and<br>Multiple or Customers'<br>Trade Name |
| Product Code | 80LYY | 80LYY |
| Classification Name | Patient examination gloves.<br>powder free<br>(per 21 CFR 880.6251) | Patient examination gloves,<br>powder free<br>(per 21 CFR 880.6251) |
| Intended Use | Provide barrier against<br>potentially infectious<br>materials and other<br>contaminants | Provide barrier against<br>potentially infectious<br>materials and other<br>contaminants |
| Composition of gloves | Natural rubber latex | Natural rubber latex |
| Color Additive | Without color additive | With or without colour<br>additive |
| Protein Content Labeling<br>Claim | Without protein content<br>labeling claim | With protein content<br>labeling claim |
| Compliance with ASTM<br>standards | ASTM D3578<br>ASTM D6124 | ASTM D3578<br>ASTM D6124<br>ASTM D5712 |
| Compliance with other<br>standards | FDA 21 CFR 800.20 | FDA 21 CFR 800.20 |
| Labeling | 21 CFR 820.120 | 21 CFR 820.120 |

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# Table 2

| Characteristics | Standards | Device Name | | Device |
|--------------------------------------------------|-------------------------------------|--------------------------------|--------------------------------|---------------------------|
| | | Unmodified<br>device | Modified<br>Device | Performance |
| Palm Width<br>(Medium) | ASTM D 3578 | 90 - 91 mm | 91 - 92 mm | Meets |
| Length (Medium) | ASTM D 3578 | 285 - 290 mm | 285 - 292 mm | Meets |
| Finger Thickness<br>(Medium) | ASTM D 3578 | 0.31 - 0.32 mm | 0.38 - 0.40 | Meets |
| Palm Thickness<br>(Medium) | ASTM D 3578 | 0.25 - 0.26 mm | 0.35 - 0.37 mm | Meets |
| Tensile Strength<br>(Unaged) | ASTM D 3578 | 19.04-32.10<br>MPa | 22.88 - 30.87<br>MPa | Meets |
| Tensile Strength<br>(Aged) | ASTM D 3578 | 16.40 - 18.35<br>MPa | 21.05 - 27.60<br>MPa | Meets |
| Freedom from<br>pinholes | ASTM D 3578<br>FDA 21 CFR<br>800.20 | 1/125 | 0/125 | Meets |
| Visual Inspection<br>- Major defects | In-House<br>Specification | 0/125 | 1/125 | Meets<br>(AQL 2.5) |
| Visual Inspection<br>- Minor defects | In-House<br>Specification | 1/125 | 1/125 | Meets<br>(AQL 4.0) |
| Powder Residual | ASTM D 3578<br>ASTM D 6124 | Avg. 1.63<br>mg/glove | Avg. 0.96<br>mg/glove. | Meets<br>< 2 mg/glove |
| Protein Content | ASTM D 3578<br>ASTM D 5712 | 21 - 24 µg/g | 17 - 29 µg/g | Meets<br>< 50 µg/g |
| Biocompatability<br>- Primary Skin<br>Irritation | 16 CFR Part 1500 | Not a primary skin<br>irritant | Not a primary skin<br>irritant | Meets<br>(Non Irritant) |
| Biocompatability<br>- Dermal<br>Sensitization | Buehler<br>Method | Not a contact<br>sensitizer | Not a contact<br>sensitizer | Meets<br>(Non Sensitizer) |

#### 9.0 Conclusion:

The Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 Micrograms or Less) will perform according to the glove performance standards as above and meet ASTM standards, and FDA requirements for waterleak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

AUG 2 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Terence Lim Sin Kooi Senior Quality Assurance/Regulatory Affairs Manager Medipure Corporation (M) SDN. BHD. Lot 12. Medan Tasek Tasek Industrial Estate, Ipoh Perak 31400 MALAYSIA

Re: K061551

Trade/Device Name: Powder Free Latex Examination Gloves, Natural or blue Colour and with Protein Content labeling Claim (50 Micrograms or less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 15, 2006 Received: August 17, 2006

Dear Mr. Kooi:

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. Kooi

ﭘﻪ ﭘﻪ

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 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 yours,

Syrtle J. Michael Omd.

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):

Device Name:

POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

### Indications For Use:

The Powder Free Latex Examination Glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on hands or finger(s) for medical purposes to provide a barrier.against potentially infectious materials and other contaminants.

Shalie R.M. Murphy, RD 8/24/04

an-Off) of Anesthesiology, General Hospical, con Control, Dental Devices

Number: K 061551

Prescription Use (Per 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)