RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR

K102902 · Rubbercare Protection Products Sdn Bhd · LYY · Apr 22, 2011 · General Hospital

Device Facts

• Record ID: K102902
• Device Name: RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR
• Applicant: Rubbercare Protection Products Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Apr 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A 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.

Device Story

Disposable latex patient examination glove; powder-free via on-line polymer-coating process. Designed for medical use to prevent contamination between patient and examiner. Tack-free surface; suitable for users sensitive or allergic to powdered gloves. Used in clinical settings by healthcare providers. Provides a physical barrier; reduces risk of cross-contamination; benefits patients and clinicians by maintaining hygiene standards.

Clinical Evidence

Bench testing only. Compliance with ASTM D3578-05 standards verified for physical dimensions, tensile strength (23.1 MPa before aging, 29.6 MPa after), ultimate elongation (770% before, 830% after), and water leak AQL (1.5). Protein content measured at ≤50 µg/glove (ASTM D5712-99c1). Biocompatibility confirmed via skin irritation and dermal sensitization testing.

Technological Characteristics

Latex material; powder-free via on-line polymer-coating. Dimensions: 290-305mm length; 0.20-0.24mm palm thickness; 0.23-0.26mm finger thickness. Complies with ASTM D3578-05 and ASTM D5712-99c1. Biocompatibility per ASTM F 720-81.

Indications for Use

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

Predicate Devices

• Powder Free Latex Examination Glove, Blue Color (K011271)

Submission Summary (Full Text)

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APR 2 2 2011

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PERUSAHAAN PELINDUNG GETAH (M) SDN BHD any No. 169997-P Lot 110. Lorong Senawang 4/3, Off Jalan Senswang no Inclustrial Estate, 70450 S Negeri Sembilan Darul Khusus, Malaysi Tcl: 60-6-6772781 Fax: 60-6-677

Image /page/0/Picture/3 description: The image shows a circular logo with the letters "LQS" in the center. The text "Quality Assured" is written around the top of the circle, and "ISO 13485:2003" is written around the bottom. Below the circle, the text "Reg. No. 322408 MP23" is written. The logo appears to be a certification mark indicating that the organization meets the requirements of the ISO 13485:2003 standard for quality management systems.

We are an ISO 13485 Cartified Glove Manufacturing Facility - Protection is in Our Name

#### 510(K) SUMMARY

PERUSAHAAN PELINDUNG GETAH (M) SDN BHD Applicant:

Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat Address Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia.

| Phone No. | 60-6-6772781 | Fax No. | 60-6-6772780 |
|---------------------|------------------------------------------------------------|---------|--------------|
| Contact Person | Lim Kwee Shyan | | |
| Date of Summary | 2nd December, 2010 | | |
| Device Information | | | |
| Trade Name | RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR | | |
| Common Name | POWDER FREE LATEX EXAMINATION GLOVE BLUE COLOR | | |
| Classification Name | Patient Examination Gloves | | |

#### Claim of Equivalence

The device is a class I latex patient examination gloves 21 CFR 880.6250,Patient Examination Glove, 80LYY which is made powder-free by a process of on-line polymer-coating, meets all the requirements of ASTM standard D 3578-05 and is substantially equivalent in safety and effectiveness to the predicate device K011271 Powder Free Latex Examination Glove, Blue Color.

#### Device Description

It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive or allergic to the powdered version of the same gloves.

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K102902

Image /page/1/Picture/1 description: The image shows a sign with the letter 'P' on it. The left side of the 'P' is a vertical rectangle filled with a speckled pattern. The curved part of the 'P' is solid black, contrasting with the white background of the sign.

## PERUSAHAAN PELINDUNG GETAH (M) SDN BHD

ot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat Senawang Industrial Estate, 70450 Seremba Negeri Sembilan Darul Khusus, Malaysia Tel: [phone]

Image /page/1/Picture/4 description: The image shows a circular logo with the text "Quality Management" at the top. Inside the circle, there is a stylized design that appears to be an acronym or initials. Below the design, the text "ISO 13485:2003" is visible, indicating compliance with a specific ISO standard. At the bottom, there is a registration number, "Reg. No. 322406 MP23".

We are an ISO 13485 Certified Glove Manufacturing Facility - Protection is in Our Name

#### Intended Use of Device

A patient examination glove is a disposable device intended for medical purposes A patient examination grove is a disposable device meetible to the more on the examination between patient and examiner.

#### Technological Characteristics

Technological Characteristics the measured parameters of the gloves (e.g. lengths, thickness, widths, physical properties, protents, etc) as a secondentiality, pinnsyle, powderlengths, "thickness," widths," priysical" properties) "propertibility, pinhole, powderfree and any other requirements.

| Parameter | ASTM<br>Specifications | Standard<br>References | Measured<br>Values | Predicate<br>Device<br>K011271 |
|--------------------------------------|------------------------|------------------------|-----------------------|--------------------------------|
| Length, mm | 230 min. | ASTM D3578-05 | 290mm-305mm | 290mm min |
| Thickness (palm), mm | 0.08 min. | ASTM D3578-05 | 0.20mm-<br>0.24mm | 0.20mm-<br>0.24mm |
| Thickness (finger), mm | 0.08 min. | ASTM D3578-05 | 0.23mm-<br>0.26mm | 0.23mm-<br>0.25mm |
| Width (size: Small), mm | $80 \pm 10$ | ASTM D3578-05 | 82 mm –<br>85 mm | 82 mm –<br>85 mm |
| Width (size: Medium), mm | $95 \pm 10$ | ASTM D3578-05 | 89 mm –<br>94 mm | 89 mm –<br>94 mm |
| Width (size: Large), mm | $111 \pm 10$ | ASTM D3578-05 | 103 mm –<br>105 mm | 103 mm –<br>105 mm |
| Tensile Strength, Before Aging, Mpa | 18 min. | ASTM D3578-05 | 23.1 Mpa | 18 Mpa min |
| Tensile Strength, After Aging, Mpa | 14 min. | ASTM D3578-05 | 29.6 Mpa | 14 Mpa min |
| Ultimate Elongation, Before Aging, % | 650 min. | ASTM D3578-05 | 770 % | 770 % |
| Ultimate Elongation, After Aging, % | 500 min. | ASTM D3578-05 | 830 % | 850 % |
| Water Extractable Protein, µg/gram | 200 µg/glove max. | ASTM D5712-99c1 | 50 µg/glove and below | 50 µg/glove and below |
| Water Leak Test, Before Aging, AQL | 2.5 | ASTM D3578-05 | 1.5 and below | 1.5 and below |
| Water Leak Test, After Aging, AQL | 2.5 | ASTM D3578-05 | 2.5 and below | 2.5 and below |
| Residual Powder (size M), mg/glove | 2 mg/glove max. | ASTM D3578-05 | 2 mg/glove and below | 2 mg/glove and below |
| Biocompatability Test | ASTM F 720-81 | | | |
| Skin Irritation Test | n.a | n.a | Passed* | Passed* |
| Dermal Sensitization Test | n.a | n.a | Passed* | Passed* |

### Substantial Equivalence Conclusions.

Supstantial Equivalence Conclusions
Based on the nonclinical test data , we certify that our gloves: Based on the nonclinical test data , we certing and effectively and effectively as the
is as safe, as effective, and performs at least as safely and effectively as the is as safe, as effective, and periorins at least as sanch en a lease Examination
legally marketed predicate device, KO12271 Powder Free Latex Examination
Collination of Canad legally marketed 'predicate' device, 'AUIT271' Forroll' From Wee

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JUN 16 2011

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Lim Kwee Shyan Chief Executive Officer Managing Director Rubbercare Protection Products Sdn Bhd Lot 110 Lorong Senawang 4/3, Off Jalan Senawang Empat Senawang Industrial Estate 70450 Seremban, Negeri Sembilan Darul Khusus MALAYSIA

- Re: K102902
Trade/Device Name: Powder Free Latex Examination Glove, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: April 5, 2011 Received: April 7, 2011

Dear Lim Kwee Shyan:

This letter corrects our substantially equivalent letter of April 22, 2011.

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 (PMA). You may, therefore, market the device, subject to the general coptvols 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 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 - Lim Kwee Shyan

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 regencies. 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); medical device reportung (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Partly 20); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket patific: ' on" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony O. norton

Anthony D. Watson, B.S., M.S., M.B.A. 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

Prescription Use

510(k) Number (if known): K102902

Device Name: Powder Free Latex Examination Glove, Blue Color

Indications for Use: A 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.

AND/OR (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Elizabeth F. Clauss-Wells

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

510(k) Number: _ K/02902