RUBBERCARE POWDERED LATEX EXAMINATION GLOVES

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image is a simple black and white image with a few small, dark spots scattered across the white background. The spots are irregularly shaped and appear to be randomly placed. The overall impression is one of sparseness and simplicity, with the dark spots providing a minimal contrast against the bright background. K032201 # PERUSAHAAN PELINDUNG GETAH (M) SDN BHD (Company No. 169997-P) Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Fax: 606-6772780 Tel: 606-6772781 Image /page/0/Picture/5 description: The image contains two logos. The logo on the left has the letters "BVQi" stacked on top of each other, with a horizontal line underneath. Below the line, the text "ISO 9001" is printed. The logo on the right has a crown above a check mark, with the text "UKAS QUALITY MANAGEMENT" printed below. Amended: October 2, 2003 (Original page 8 of 20) ## 510(K) SUMMARY | Applicant: | PERUSAHAAN PELINDUNG GETAH (M) SDN BHD | | | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------|--------------| | Address | Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat<br>Senawang Industrial Estate, 70450 Seremban,<br>Negeri Sembilan, Malaysia. | | | | Phone No. | 60-6-6772781 | Fax No. | 60-6-6772780 | | Contact Person | Peter Yew Nieng Choon | | | | Date of Summary | October 2, 2003 | | | | Device Information | | | | | Trade Name | RUBBERCARE | | | | Common Name | Powdered Latex Exam Gloves | | | | Classification Name | Patient Examination Glove, powdered | | | ## Claim of Equivalence The device is a class I latex patient examination gloves 80LYY powdered with absorbable dusting powder, that meets all the requirements of ASTM standard D 3578-01a2. ## Device Description It is made from natural rubber latex using USP cornstarch as donning powder. The manufacturing process includes pre and post leaching stages to remove residual chemicals and water-soluble proteins. The extent of protein removal is within the limit of the ASTM D3578-01a24 recommended limits for both powder and water-soluble protein. {1}------------------------------------------------ ## PERUSAHAAN PELINDUNG GETAH (M) SDN BHD (Company No. 169997-P) Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat, Senawang Industrial Estate, 70450 Seremban. Negeri Sembilan Darul Khusus, Malaysia Tel: 606-6772781 Fax: 606-6772780 Image /page/1/Picture/2 description: The image contains two logos. The logo on the left has the letters "BVQi" stacked on top of each other, with the text "ISO 9001" underneath. The logo on the right has a crown above a check mark, with the text "UKAS QUALITY MANAGEMENT" underneath. Amended: October 2, 2003 (Original page 9 of 20) ### Intended Use of Device The device is intended as a protective device to be worn on the examiner's hand or finger to prevent contamination between patient and examiner. ### Technological Characteristics Following is a table showing the measured parameters of the gloves (e.g. lengths, thickness, widths, physical properties, protein contents, etc) as compared to ASTM. Also data that meets FDA biocompatibility, pinhole, and any other requirements, and any other parameter on which we want to make a labeling claim. | Parameter | ASTM Specifications | Measured Values | |--------------------------------------|---------------------|----------------------| | Length (sizes M, L), mm | 230 min. | 240 - 245 | | Thickness (palm), mm | 0.08 min. | 0.14-0.16 | | Thickness (finger), mm | 0.08 min. | 0.16-0.20 | | Width (size M), mm | $95 \pm 10$ | 94 - 98 | | Tensile Strength, Before Aging, Mpa | 18 min. | 20 - 29 | | Tensile Strength, After Aging, Mpa | 14 min. | 20 - 26 | | Ultimate Elongation, Before Aging, % | 650 min. | 750 - 900 | | Ultimate Elongation, After Aging, % | 500 min. | 750-950 | | Water Extractable Protein, µg/gram | 200µg/dm² | 100µg/gram and below | | | (recommended) | | | Water Leak Test, Before Aging, AQL | 2.5 | 1.5 and below | | Water Leak Test, After Aging, AQL | n.a. | 2.5 and below | | Residual Powder, mg/dm² | 10 | 9-10 | | Skin Irritation Test | n.a | Passed* | | Dermal Sensitization Test | n.a | Passed* | * Please refers to attachment H (page 19) #### Conclusions Based on the test data given above, we certify that our gloves: - meet or exceed the ASTM standard D3578-01a22 a. - b. meet the FDA pinhole requirements; and - c. meet our labeling claim on protein content. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## OCT 1 0 2003 Mr. Peter Yew Nieng Choon Managing Director Perusahaan Pelindung Getah (M) SDN BHD Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Darul Khusus, MALAYSIA #### Re: K032201 Trade/Device Name: Rubbercare Powdered Latex Examination Gloves (containing 100 Micrograms or Less of Total Water Extractable Protein Per gram) Regulation Number: Patient Examination Glove Regulation Name: 880.6250 Regulatory Class: I Product Code: LYY Dated: October 2, 2003 Received: October 6, 2003 Dear Mr. Nieng Choon: 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. {3}------------------------------------------------ Page 2 - Mr. Nieng Choon 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 vour 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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. 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 {4}------------------------------------------------ ## PERUSAHAAN PELINDUNG GETAH (M) SDN BHD (Company No. 169997-P) Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Fax: 606-6772780 Tel: 606-6772781 Image /page/4/Picture/2 description: The image contains two logos. The logo on the left has the letters "BVQi" in a bold, sans-serif font, with a horizontal line above and below the letters. Below the logo, the text "ISO 9001" is printed. The logo on the right has a check mark above the text "UKAS QUALITY MANAGEMENT". Amended: October 2, 2003 (Original page 3 of 20) ## INDICATIONS FOR USE PERUSAHAAN PELINDUNG GETAH (M) SDN BHD Applicant: K032201 510(k) No. RubberCare Powdered Latex Examination Gloves (containing 100 Device Name: micrograms or less of total water extractable protein per gram) #### Indications for Use The RubberCare powdered latex examination glove is a disposable device intended for medical The Raober on on the examiner's hand or finger to prevent contamination between patient and examiner. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sat. Pat. fx. Chan-Len (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K032201 Prescription Use (Pcr 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)