SURGEON'S GLOVE

{0}------------------------------------------------ SEP 1 0 1998 Image /page/0/Picture/1 description: The image shows a logo for Shiva. The logo consists of a black triangle with a white "S" shape inside. Below the triangle, the word "SHIVA" is written in a bold, sans-serif font. The logo is simple and modern, with a focus on the geometric shape and the company name. 71 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/ | | FAX NO | : 91-44-2368327 | | EMAIL | : shivam@md2.vsnl.net.in | | CONTACT PERSON | : MR. SATISH JAIN<br>EXECUTIVE DIRECTOR. | | 3. DEVICE TRADE NAME | : NIL | | COMMON NAME | : Surgeon's Glove | | Classification Name | : Surgeon's Glove | - 4. Legally marketed device to which the company claiminng equivalence: Class I Surgeon's Glove 79KGOthat meets all the requirements of ASTM D3577. - 5. DESCRIPTION OF THE DEVICE : Class I Surgeon's Glove 79KGO powdered with Absorbable Dusting Powder that meets all 'the requirements of ASTM D3577. Intended use of the Device: 6.0 Surgeon's glove is a Medical Device intended tobe worn by Operating room personnel to protect a surgical wound from contamination. Image /page/0/Picture/10 description: The image shows the logo for Shiva Medicare Limited. The logo includes a plus sign with the word "Medicare" written diagonally across it. Below the company name is the text "(A 100% Export Oriented Unit)". Registered Office & Works : A 15-17, M.E.P.Z., Kadaperi, Tambaran, Chennai - 600 043 (INDIA) Phones : 044/2368011/2368322 EMAIL: 5 hivan @md2.vsnl-net.in Telefax : 091-44-2368327. Grams : "SHIVMEDI Cornorate Office : 808, Pragati Tower, 26, Rajendra Place, New Delhi - 110 008 (INDIA) {1}------------------------------------------------ K982589 \$P^{2/5}\$ \$^{72}\$ - 7.0 Technological characteristics of the device compared to predicate device. | Measured Parameters of Latex<br>Surgeon's Glove manufactured by Shiva<br>Medicare Ltd., | | | ASTMD3577<br>Requirement for<br>Latex Surgeons glove | |-----------------------------------------------------------------------------------------|------|-------------|------------------------------------------------------| | Characteristics | SIZE | Value | | | 1. Length | 5 ½ | 270- 272 mm | 245 mm minimum | | | 6 | 270-272mm | 265 mm minimum | | | 6 ½ | 270-272mm | 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 +/- 6 mm | | | 6 ½ | 79 mm | 83 +/- 6mm | | | 7 | 87mm | 99 +/- 6mm | | | 7 ½ | 92mm | 95 +/- 6mm | | | 8 | 103mm | 105+/- 6mm | | | 8 ½ | 106mm | 108+/- 6mm | | | 9 | 112mm | 114 +/- 6mm | - Thickness at cuff , Palm and finger tip of all the size is 0 .12,0 .16 and 3. I hickness at curr, Failf and imger tip of all atthess specified at cuff palm and finger tip is 0.1 mm. PHYSICAL PROPERTIES: | | BEFORE AGEING | | AFTER AGEING | | |-------------------------------------------|---------------|----------------------|----------------|--------------------------| | Characteristics | SML Value | ASTM<br>D3577 | SML Value | ASTD 3577<br>Requirement | | Tensile Strength<br>Elongation at break % | 27 mpa | 24 mpa (min)<br>750% | 20 mpa<br>750% | 18 mpa min<br>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 "SHIVA MEDICAL" around the top half of the circle. In the center of the circle are the words "Madras-600 045." There is a star on the left side of the circle. {2}------------------------------------------------ 73 K982589 P3/5 ## PERFORMANCE REQUIREMENT: | Characteristics | Related defects | Level Followed | | AQL<br>followed | AQL as per<br>ASTM D3577. | |-----------------------|-------------------------------------------------------------------------------|----------------|------------|-----------------|---------------------------| | | | SML | ASTM D3577 | | | | Sterility | Fails sterility | As per IP | Asper USP | NA | NA | | Freedom from<br>Holes | Holes | S4 | | 1.5 | 1.5 | | Dimension | Width, Length<br>Thickness. | S2 | S4 | 4 | 4 | | Physical<br>Property | Tensile<br>strength,<br>Elongation at<br>break before<br>and after<br>ageing. | S2 | S2 | 4 | 4 | ### POWDER CONTENT | Class of the first for the proposal and a property and the program and the program | AND A BOLL CONSULTION OF CHILINGS OF COLLEGION OF COLLEGIONAL CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contract of Children Comments of Children Commendent Commend Comments of Children | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | SML VALUE | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ASTM REQUIREMENT | | " would be the program and the first and the commend of the county of | Annual Party of Controller of Concession of Concession Company of Concession of Concession of Concession of Concession of Concession of Concession of Concession of Concession | | Comments of the controlled by the first of the first and the first and<br>20<br>120 +/-<br>The state of the state of the state of the same of the same of the same of the same of the see and | A<br>Comments of Actively more and the became of the many of the may be any and the comments of the comments of the count | # PROTEIN CONTENT: | | ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー | |----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SML VALUE | FDA REQUIREMENT<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | www.comment.com/sport/space/article/space/a/memore/sport/arm-sological/sport/arm-<br>80 +/- 20 ppm | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Value not fixed.<br>Comments of the contract and the control of the contribution of the status and the status and the status and the status of the status of the status and | # MOISTURE CONTENT: | and the first and the many of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of<br>SML VALUE | - All Child Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children<br>STATUTE OF CLEASE OF COLLECTION OF CLEASE OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF CLEASURES OF COLLECTION OF COLLECTION OFFICE OF COLLECTION<br>FDA REQUIREMENT | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | with the state of the many of the many of the many of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comm<br>0.8% max<br>In the superior for the first and the provinced and commended of the provinces on the relation of the management of the many of the many of the many of the many of the many o | No value fixed | ### BIOCOMPATABILITY: | Comments of the contraction of the commended to the compressional consistence and consistences and consistences and consistences and consistences and consistences and consist<br>SML GLOVE | FDA REQUIREMENT | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Biologically Compatable<br>Annual property of the first of the "luck" | Biologically Compatable | Image /page/2/Picture/11 description: The image shows a circular stamp with the words "SHIVA MEDICARE" around the top edge. In the center of the stamp, the word "Madras" is written above the number "600 045.". The stamp appears to be slightly tilted. {3}------------------------------------------------ K982589 p\$^{4/5}\$ Price ### 8.0 Performance Data: The performance test data of the surgeons gloves manufactured by Shiva Medicare Limited is given below. | Measured Parameters if Latex | | | |--------------------------------------|------|--------------| | Surgeon's gloves (Powder free) | | | | manufactured by Shiva Medicare Ltd., | | | | Characteristics | SIZE | Value | | 1. Length | 5 ½ | 270 mm | | | 6 | 270 - 272mm | | | 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 | 68mm | | | 6 | 73mm | | | 6 ½ | 79mm | | | 7 | 87mm | | | 7 ½ | 92mm | | | 8 | 103mm | | | 8 ½ | 106mm | | | 9 | 112mm | - Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0.16 and 3. 0.19. mm. # PHYSICAIL PROPERTIES: | Characterstics | Before Ageing | After Ageing | |---------------------------------|---------------|--------------| | Tensile Strength | 27 mpa | 20 mpa | | Elongation at break % | 850% | 750% | | Modulus at 500 %<br>elongation. | 3 mpa | - | {4}------------------------------------------------ K98 2589 P 515 ### 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 : 120 +/ - 20 PROTEIN CONTENT: 80 +/- 20 ppm MOISTURE CONTENT: 0.8% max BIOCOMPATABILITY: Biologically Compatable. NA 9. Clinical Data " ### 10. CONCLUSION OF PERFORMANCE TEST DATA: The Surgeon's gloves manufactured by Shiva Medicare Limited - Meet or exceed the ASTM D3577 ﺴ - Meet FDA Pin hole Requirement. - - Meet labelling 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/15 description: The image shows a circular stamp with the words "SHIVA MEDICALS" written along the top arc. The words "Madras - 600 045." are written in the center of the stamp. The stamp appears to be black ink on a white background. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circle's perimeter. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 0 1998 M/s. Shiva Medicare Ltd. C/O Mr. James F. Logan Medical Reports Exchange 314 North Hunter Street Baltimore, MD 21202 Re: K982589 Trade Name: Surgeon's Glove, Latex Powdered Free Regulatory Class: I Product Code: KGO Dated: June 30, 1998 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 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 (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 general 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. Butman 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. | K982589 | | DEVICE NAME | SURGEON'S GLOVE | INDICATIONS FOR USE: Prescription Use (Pct 21 CFR 801.109) Surgeon's glove is a medical device intended to be worn by operating room personnel 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) | OR | Over-The-Counter Use | |----|----------------------| |----|----------------------| | | Neure 1. Meir fer | |---------------------------------------------------------------------|--------------------------| | (Division Sign-Off) | Ulin S. Zin, PhD | | Division of Dental, Infection Control, and General Hospital Devices | (Optional Format 1-2-96) | | 510(k) Number | K982588 | |---------------|---------| |---------------|---------|