BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE

K062526 · Multisafe Sdn. Bhd. · LYY · Apr 13, 2007 · General Hospital

Device Facts

• Record ID: K062526
• Device Name: BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
• Applicant: Multisafe Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Apr 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Blue Powdered Latex Examination Gloves, Non-sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as barrier against potentially infectious materials and other contamination.

Device Story

Blue Powdered Latex Examination Gloves are disposable, non-sterile natural rubber latex gloves. Used by healthcare and similar personnel as a protective barrier against infectious materials, bodily fluids, waste, and environmental contaminants. Device functions as a physical barrier; worn on hands. No electronic, software, or algorithmic components. Performance verified via water leak testing, dimensional analysis, physical property testing (tensile strength/elongation), and biocompatibility assessments (dermal irritation/sensitization).

Clinical Evidence

Bench testing only. No clinical data. Testing included water leak test (AQL 1.5), dimensions, palm width, thickness, tensile strength (min 18 MPa before aging, 14 MPa after), ultimate elongation (min 700% before, 500% after), powder content (ASTM 6124, <10.0 mg/glove), protein content (ASTM 5712, <200 µg/dm²), and biocompatibility (primary dermal irritation and dermal sensitization studies).

Technological Characteristics

Material: Natural rubber latex, ZDBC, ZDEC, sulphur, zinc oxide, Tamol, titanium dioxide, modified corn starch, Flexobrite Blue pigment. Dimensions: 290mm length. Standards: ASTM D3578, ASTM 6124, ASTM 5712. Non-sterile. Powdered.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier on hands against infectious materials, fluids, waste, or environmental contamination. Intended for disposable use.

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

• Multisafe Powdered Latex Examination Gloves (K993811)

Submission Summary (Full Text)

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K062526

## 17.0 SMDA 510(K) SUMMARY

APR 1 3 2007

| 1. | Applicant | : | MULTISAFE SDN. BHD<br>Lot 764, Bidor Industrial Estates,<br>35500 Bidor,<br>Perak Darul Ridzuan,<br>Malaysia. |
|----|--------------------------|---|---------------------------------------------------------------------------------------------------------------|
| | Tel No. | : | 605-4348269 |
| | Fax No | : | 605-4348266 |
| | Name of Contact Person | : | 1. Mr. Abd Hadi bin Husin<br>2. Ms. Rosnani Binti Hassan Besari |
| | Date of Summary Prepared | : | 28th February 2007 |
| 2. | Name of Device | | |
| | Trade Name | : | Blue Powdered Latex Examination<br>Glove, Non-Sterile |
| | Common Name | : | Examination Gloves |
| | Classification Name | : | Patient Examination Gloves (Class 1 in<br>US and European markets, Class IIa in<br>Canadian Market) |

## 3. Identification Of the Legally Marketed Devices

Latex Patient Examination Gloves LYY, Powdered that meets all the requirements of FDA, ASTM D 3578, ISO 11193, EN 455 : Part 1, Part 2 and Part 3, CMDR, MDR and CGSB.

.

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#### Description Of the Devices 4.

Latex Patient Examination Gloves, LYY, Powdered

#### 5. The Intended Use of Glove

A medical glove is worn on the hands of healthcare and similar personnel as a barrier against potentially infectious materials and other contamination between healthcare and patient's body, fluid, waste or environment.

- The Quality performance of the glove are shown in the table above (. meets ASTM D 3578-01 Standard and FDA's requirement
- The Biocompatibility Test consists of Primary Dermal Irritation Study 7. And the Dermal Sensitization Study. The gloves pass the Biocompatibility Test.

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## Summary of Quality Performance 8.

...

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The Quality Performance of gloves based on the requirements stated in item 6.

| TEST | REQUIREMENT | IN-HOUSE QUALITY<br>PERFORMANCE |
|-------------------------------------|--------------|---------------------------------|
| 1. Water Leak Test<br>(1000ml) | GII, AQL 2.5 | Pass GI, AQL 1.5 |
| 2. Length (mm)<br>Size: XS | Min. 220 | Minimum 290 mm for all<br>sizes |
| S | Min. 230 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | - | |
| 3 Palm Width (mm)<br>Size : XS | $70\pm10$ | 75-78 |
| S | $80\pm10$ | 82-86 |
| M | $90\pm10$ | 92-95 |
| L | $100\pm10$ | 103-109 |
| XL | - | 111-115 |
| 4. Thickness (mm)<br>(Single layer) | | |
| Finger | Min 0.08 | Min 0.10 |
| Palm | Min 0.08 | Min 0.10 |
| 5. Physical<br>Properties | | |
| Before Ageing | | |
| Tensile Strength (MPa) | Min. 14 | Min 18 |
| Ultimate Elongation (%) | Min 700 | Min 700 |
| After Ageing | | |
| Tensile Strength (MPa) | Min.14 | Min. 14 |
| Ultimate Elongation (%) | 500 | 500 |
| 6. Powder Content | ASTM 6124 | Below 10.0 mg/glove |
| 7. Protein Content | ASTM 5712 | Below 200 µg/dm² |

14

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#### Conclusion 9.

We concluded that the Blue Powdered Latex Examination Gloves, Protein Content Labeling (200 µg/dm2 or less), Non-Sterile meets:

- ASTM D3578 Standard
- · FDA pin hole requirement
- FDA minimum powder residual content
- · CMDR requirement
- CGSB requirement
- · Label Claim of 200 µg/dm2 or less of total water extractable protein content

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......

. Comparison table and discussion of the similarities and difference of Blue Powdered Latex :amination Gloves (Non-Sterile) compared to Multisafe Powdered Latex Examination Gloves, (Non-.. erile).

| No | Description | Requirement | 510K No | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------|------------------------|
| | | | K993811 | K062526 |
| 1 | Water Tight Test<br>(1000ml) | GII, AQL 2.5 | Pass GI, AQL 1.0 | Pass GI, AQL 1.5 |
| 2 | Dimension Test | Min. 290 (Long Glove)<br>Min. 230 (Short Glove) | Min 230 for all sizes | Min 290 for all sizes |
| 3 | Palm Width (mm) | XS : 70 +/- 10<br>S : 80 +/- 10<br>M : 90 +/- 10<br>L :100 +/- 10 | Meet the specification | Meet the specification |
| 4 | Thickness (mm)<br>i) Finger<br>ii) Palm | Min. 0.08<br>Min. 0.08 | Meet the specification | Meet the specification |
| 5 | Physical Properties (Before<br>Aging)<br>i) Tensile Strength<br>(Mpa) | Min 14 | Min 18 | Min. 18 |
| | ii) Ultimate<br>Elongation (%) | Min. 700 | Min. 700 | Min. 700 |
| | Physical Properties<br>(After Aging) | | | |
| | i) Tensile Strength<br>(Mpa) | Min. 14 | Min. 14 | Min. 14 |
| | ii) Ultimate<br>Elongation (%) | Min. 500 | Min. 500 | Min. 500 |
| 6 | Powder Content | ASTM 6124 | Meet the specification | Below 10.0mg/glove |
| 7 | Protein Content | ASTM 5712 | Meet the specification | Below 200 µg/dm² |
| 8 | Biocompatibility Test<br>i) Primary Skin<br>Irritation | No Animal Irritation | Yes | Yes |
| | ii) Dermal<br>Sensitization Assay<br>(Animal Study) | No Animal Irritation | Yes | Yes |
| 9 | Colour Extraction | Others | Normal Creamy<br>White | Blue Colour |
| 10 | Ingredient<br>a) Latex<br>b) Accelerators<br>c) Antioxidant<br>d) Curing Agent<br>e) Activator | Natural Rubber latex<br>ZDBC<br>ZDEC<br>Sulphur<br>Zinc Oxide | √ | √ |
| f) Dispersing Agent<br>g) Filler / Pigment<br>h) Donning Powder<br>i) Pigment | Tamol<br>Titanium Dioxide<br>Modified Corn Starch<br>Flexobrite Blue | | | |
| | | √<br>√<br>√<br>X | √<br>√<br>√<br>√ | |

1 ୧

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:

:

Conclusion :

125

P

1

e Blue Powdered Latex Examination Gloves (Non-Sterile) is similar with Multisafe Powdered Latex Examination Gloves (Non-Sterile) except the dimension of length and colour extraction (

MULTISAFE SDN. BHDA

R ABD HADI HUSIN (Plant Mahager)

। ।

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 3 2007

Mr. Abd Hadi Bin Husin Quality Management Representative/Plant Manager Multisafe Sdn Bhd Lot 764, Bidor Industrial Estate 35500 Bidor Perak Darul Ridzuan MALAYSIA

Re: K062526

Trade/Device Name: Blue Powdered Latex Examination Gloves, Non-Sterile Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: February 14, 2007 Received: March 19, 2007

Dear Mr. Husin:

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. Husin

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/industry/support/index.html.

Sincerely yours,

Sylitte Y. Micham Om.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

510(k) Number (if known): K062526

Device Name: Blue powdered latex Examination Gloves, Non-sterile

Indications For Use:

Blue Powdered Latex Examination Gloves, Non-sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as barrier against potentially infectious materials and other contamination.

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)

Stales H.M. Murphy, bo

(K) Number K 062526

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