POWDER FREE SURGEONS GLOVE

{0}------------------------------------------------ AUG | | | 1998 Image /page/0/Picture/1 description: The image shows a close-up of handwritten numbers and a letter. The numbers "98" and "2586" are visible, along with the letter "K". A horizontal line is drawn beneath the numbers, possibly indicating a total or a separation of values. The handwriting appears to be done with a thick marker or pen, giving the characters a bold and somewhat rough texture. Image /page/0/Picture/2 description: The image shows a logo with a triangular shape at the top and the word "SHIV" written below it. The triangle is filled with a dark color, and there is a white letter "S" inside the triangle. The word "SHIV" is written in bold, uppercase letters. :17 1. 510K SUMMARY as required by: 807.92( c ) #### 1.0 APPLICANT | NAME | M/s. SHIVA MEDICARE LIMITED | |---------|---------------------------------------------------------------------------------------------------------| | ADDRESS | A 15, 16, 17(PART)<br>MADRAS EXPORT PROCESSINGZONE<br>KADAPERI, TAMBARAM,<br>CHENNAI 600 045.<br>INDIA. | | PH.NO. | : 91-44-2368011/2368322/2362656/2362657. | | FAX NO | : 91-44-2368327 | | EMAIL | : shivam@md2.vsnl.net.in | #### CONTACT PERSON: MR. SATISH JAIN EXECUTIVE DIRECTOR. 3. DEVICE TRADE NAME : NIL .. Surgeon's Glove COMMON NAME : Powder free Surgeon's Glove Classification Name - 4. Legally marketed device to which the company claiming equivalence: Class I Surgeon's Glove ( Powder free) 79KGOthat meets all the requirements of ASTM D3577. - 5. DESCRIPTION OF THE DEVICE : Class I Powder free Surgical Glove 79KGO that meets all the requirements of ASTM D3577. Intended use of the Device: 6.0 Powder free Surgeon's glove is a Powder free Medical Device intended tobe worn by Operating room personnel to protect a surgical wound from contamination. Image /page/0/Picture/15 description: The image shows a logo for Shiva Medicare LTD. The logo features a black cross with the word "MEDICARE" written diagonally across it. Below the cross is a circular seal with the words "SHIVA MEDICARE LTD" around the edge and "Madras-600 045" in the center. **Shiva Medicare Limited** (A 100% Export Oriented Unit) Registered Office & Works : A 15-17. M.E.P.Z., Kadaperi, Tambaram, Chenna1 - 600 045 (INDIA) Phones : 044/2368011/2368322 EMAIL: Shivani @md2.vsnl-net.in Telefax : 091-44-2368327. Grams : "SHIVMEDI" Corporate Office : 808, Pragaii Tower, 26, Rajendra Place, New Delhi - 110 008 (INDIA) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {1}------------------------------------------------ # 7.0 Technological characteristics of the device compared to predicate device. | Measured Parameters of Latex<br>Surgeon's gloves (Powder free)<br>manufactured by Shiva Medicare Ltd., | | | ASTM D3577<br>Requirement for<br>Latex Surgeon's glove<br>(Powder free) | |--------------------------------------------------------------------------------------------------------|------|---------------|-------------------------------------------------------------------------| | Characteristics | SIZE | Value | | | 1. Length | 5 ½ | 270-272 mm | 245 mm minimum | | | 6 | 270 – 272 mm | 265 mm minimum | | | 6 ½ | 270 - 272 mm | 265 mm minimum | | | 7 | 270 - 272 mm | 265mm minimum | | | 7 ½ | 270 –272 mm | 265 mm minimum | | | 8 | 270 -272 mm | 265 mm minimum | | | 8 ½ | 270 -- 272 mm | 265 mm minimum | | | 9 | 270 - 272 mm | 265 mm minimum | | 2. Width | 5 ½ | 68 mm | 70 +/- 6 mm | | | 6 | 73mm | 76 +/- 6mm | | | 6 ½ | 79mm | 83 +/- 6 mm | | | 7 | 87mm | 99 +/- 6 mm | | | 7 ½ | 92mm | 95 +/- 6 mm | | | 8 | 103mm | 105+/- 6 mm | | | 8 ½ | 106mm | 108+/-6 mm | | | 9 | 112mm | 114+/-6 mm | - 3. Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0 .16 and 0.19mm. ASTM D3577 requirement for thickness at cuff, palm and finger tip is 0.1 mm minimum. # PHYSICAL PROPERTIES: | BEFORE AGEING | | AFTER AGEING | | | |---------------------------------|-----------|------------------------------|-----------|------------------------------| | Characteristics | SML Value | ASTM<br>D3577<br>Requirement | SML Value | ASTM<br>D3577<br>Requirement | | Tensile Strength | 27 mpa | 24 mpa | 20 mpa | 18 mpa min | | Elongation at break % | 850% | 750% | 750% | 560% min | | Modulus at 500 %<br>elongation. | 3 mpa | 5.5 mpa<br>(max) | - | - | Image /page/1/Picture/6 description: The image shows a circular stamp with the words "AAIHA MEDICARE LTD" around the outer edge. Inside the circle, the text "Madras-600 045" is visible. The stamp appears to be somewhat faded or worn, giving it a vintage or official document-like appearance. {2}------------------------------------------------ ## ERFORMANCE REQUIREMENT: | Characteristics | Related<br>defects | Level followed<br>By<br>SML | Level As<br>per ASTM<br>D 3577 | AQL followed | AQL as per ASTM<br>D3577. | |-----------------------|-------------------------------------------------------------------------------|-----------------------------|--------------------------------|--------------|---------------------------| | Sterility | Fails sterility | As per IP* | As per<br>USP*. | NA | NA | | Freedom from<br>Holes | Holes | S4 | S4 | 1.5 | 1.5 | | Dimension | Width ,<br>Length<br>Thickness. | S2 | S2 | 4 | 4 | | Physical<br>Property | Tensile<br>strength ,<br>Elongation at<br>break before<br>and after<br>ageing | S2 | S2 | 4 | 4 | ## IP – INDIAN PHARMACOPEA #### OWDER CONTENT | CIT 57<br>ﻟ<br>STATUTE OF COLUMN | ARFOURFMENT<br>A C'T'T | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | Nil P<br>Powder<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | mo/olove<br>max | ## PROTEIN CONTENT: | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>CONTINE<br>1 - 1 - 1 | DE CITIENTT | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------| | 00<br>mmm<br>Actually College<br>A & Acres and assessment compares<br>of the property of the a second and in any of<br>Property of Canadian College of Children | alue not fixed.<br>STATUTE OF COLUMN OF CHEARTH AND THE PERSONAL PROPERTY | #### MOISTURE CONTENT: | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>THE PHONOR A - A - A 16 - 415 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411<br>A STATUS MARK VITE THE THE STORE THE<br>דיין<br>***<br>AN VALUE<br>A bear and and all different the later the later the later than | דיד גדוד לוח לה במוז<br>TY-13<br>TT<br>1<br>- | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 00<br>mau<br>11 1641<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>and and and the proposed for at the first can a first a program and | CMILD<br>TIVAC<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>www.bandrer and the transmit of the company of the company of the company of the company of the first to the country of the first to the company of the company of the first t | #### BIOCOMPATABILITY: | SML GLOVE | FDA REQUIREMENT | |-------------------------|-------------------------| | Biologically Compatible | Biologically Compatible | Image /page/2/Picture/11 description: The image shows a circular stamp with the text "SHIVA MEDICARE LTD" around the border. In the center of the stamp, the text "Madras-600 045" is visible. The stamp appears to be of low quality, with some blurring and distortion. {3}------------------------------------------------ ## 8.0. Performance Data: The performance test data of the powder free surgical gloves manufactured by Shiva Medicare Limited is given below. | Measured Parameters of Latex | | | |--------------------------------------|------|--------------| | Surgeon's gloves (Powder free) | | | | manufactured by Shiva Medicare Ltd., | | | | Characteristics | SIZE | Value | | 1. Length | 5 ½ | 270 – 272 mm | | | 6 | 270 – 272 mm | | | 6 ½ | 270 – 272 mm | | | 7 | 270 – 272 mm | | | 7 ½ | 270 – 272 mm | | | 8 | 270 – 272 mm | | | 8 ½ | 270 – 272 mm | | | 9 | 270 – 272 mm | | 2. Width | 5 ½ | 68 mm | | | 6 | 73 mm | | | 6 ½ | 79 mm | | | 7 | 87 mm | | | 7 ½ | 92 mm | | | 8 | 103 mm | | | 8 ½ | 106 mm | | | 9 | 112 mm | - 3. Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0.16 and 0.19 mm. PHYSICAL PROPERTIES: | Characteristics | Before Ageing | After Ageing | |---------------------------------|---------------|--------------| | Tensile Strength | 27 mpa | 20 mpa | | Elongation at break % | 850% | 750% | | Modulus at 500 %<br>elongation. | 3 mpa | - | Image /page/3/Picture/6 description: The image shows a circular stamp with the text "SHIVA MEDICARE LTD" around the outer edge. Inside the circle, the text "Madras-600 045" is printed. The text is in a simple, sans-serif font and is arranged in a way that it fills the circular space effectively. The stamp appears to be somewhat worn, with some parts of the text slightly faded or smudged. {4}------------------------------------------------ #### PERFORMANCE REQUIREMENT: | Characteristics | Related defects | LEVEL | AQL | |-----------------------|--------------------------------------------------------------------------------|------------------------------|-----| | Sterility | Fails sterility | As per Indian<br>Pharmacopea | | | Freedom from<br>Holes | Holes | S4 | 1.5 | | Dimension | Width , Length<br>Thickness. | S2 | 4 | | Physical<br>Property | Tensile<br>strength ,<br>Elongation at<br>break before<br>and after<br>ageing. | S2 | 4 | POWDER CONTENT : 1 + /- 1 mg per Glove PROTEIN CONTENT: 80 +/- 20 ppm MOISTURE CONTENT: 0.8 % max BIOCOMPATABILITY: Biologically Compatible NA 9. Clinical Data : 10. CONCLUSION OF PERFORMANCE TEST DATA: The Powder free Surgeon's gloves manufactured by Shiva Medicare Limited Meet or exceed the ASTM D3577 - - Meet FDA Pin hole Requirement. - - Meet labeling claim as shown by the data in 6 - 11. ANY OTHER INFORMATION: Any other information required by FDA regarding product safety and effectiveness will be provided on request. Image /page/4/Picture/14 description: The image shows a circular seal with the text "AHIA MEDICARE LT" around the outer edge. Inside the circle, the text "Madras-600 045" is printed. The text is in a simple, sans-serif font and is arranged to fit within the circular shape of the seal. The seal appears to be a stamp or an official mark, possibly from a medical or healthcare-related organization located in Madras (now Chennai), India. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with a wing-like shape extending from the head. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG | | 1998 M/s. Shiva Medicare Ltd. C/O Mr. James F. Logan Medical Reports Exchange 314 N Huntet Street Baltimore, Maryland 21202 Re : K982586 Sterile Powder-Free Surgical Glove, Trade Name: Disposable Regulatory Class: I Product Code: KGO July 24, 1998 Dated: Received: July 24, 1998 Dear Mr. Logan: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {6}------------------------------------------------ Page 2 - Mr. Logan the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, S. Dutram for Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ #### 3.0 INDICATIONS FOR USE: | APPLICANT | SHIVA MEDICARE LIMITED | |-------------|-----------------------------| | 510(K) No. | K98 2586 | | DEVICE NAME | POWDER FREE SURGEON'S GLOVE | INDICATIONS FOR USE: Powder free Surgeon's glove is a sterile powder free medical device intended to be worn I oncer free bargen ersonnel to protect a surgical wound from contamination. # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Qim S. L Division Sign. 280 Division Sign-( iff) Division of Der. Infection Control, ind General Hospital Devices "10(k) Number Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use X (Optional Format 1-2-9