LATEX SURGEONS GLOVE (POWDERED)

{0}------------------------------------------------ # MAY 1 4 2002 PAGE NO : 70 1. 510K SUMMARY as required by: 807.92(c) K014278 #### 1.0 APPLICANT | NAME | : BRIGHTWAY GLOVES PVT.LTD | |---------|----------------------------------------------------------------------------------------------| | ADDRESS | : PIONEER MANIKANDAN BUILDINGS,<br>VADASERY<br>NAGAR COIL,<br>TAMIL NADU,<br>INDIA – 629001. | | PH.NO. | : 91-4652-276291, 276046. | | FAX NO | : 91-4652-274271 | #### CONTACT PERSON : N. PARAMASIVAN : MANAGING DIRECTOR . - 3. DEVICE TRADE NAME : NIL COMMON NAME : Surgeon's Glove : Surgeon's Glove (powdered) Classification Name - 4. Legally marketed device to which the company claiming equivalence: Class I Surgeon's Glove ( Powdered) 79KGOthat meets all the requirements of ASTM D3577. - 5. DESCRIPTION OF THE DEVICE : Class I Powdered Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577. 6.0 Intended use of the Device: Powdered Surgeon's glove is a sterile Medical Device intended tobe worn by Operating room personnel to protect a surgical wound from contamination and is powdered with a absorbable dusting powder USP corn starch as a donning Lubricant. Image /page/0/Picture/15 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the edge of the circle. In the center of the circle, the word "NAGERCOIL" is written in large, bold letters. There is a five-pointed star at the bottom of the circle. {1}------------------------------------------------ ## PAGE NO : 71 7.0 Technological characteristics of the device compared to predicate device. | | | | ASTM D3577 | |----------------------------------|------|--------------|----------------------------------------| | Measured Parameters of Latex | | | Requirement for | | Surgeon's gloves (Powdered) | | | | | manufactured by Brightway Gloves | | | Latex Surgeon's glove<br>(Powder free) | | Pvt.Ltd | | | | | 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 | *BGPL Value | ASTM<br>D3577<br>Requirement | BGPL 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) | - | - | . . . *Brightway Gloves Pvt.Ltd Image /page/1/Picture/8 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the edge. In the center of the stamp, the word "NAGERCOIL" is written in bold letters. There is a small star-like symbol at the bottom of the stamp. The stamp appears to be slightly faded or worn, giving it a vintage look. {2}------------------------------------------------ PAGE NO : 72 | PERFORMANCE REQUIREMENT: | | | | | | |--------------------------|----------------------------------------------------------------------|---------------------------|--------------------------|----------------------|------------------------| | Characteristics | Related defects | Level followed By<br>BGPL | Level As per ASTM D 3577 | AQL followed By BGPL | AQL as per ASTM D3577. | | Sterility | Fails sterility | As per IP* | As per USP*. | NA | NA | | Freedom from Holes | Holes | S4 | S4 | 1.5 | 1.5 | | Dimension | Width,<br>Length<br>Thickness. | S2 | S2 | 4 | 4 | | Physical Property | Tensile strength,<br>Elongation at break before<br>and after ageing. | S2 | S2 | 4 | 4 | # IP – INDIAN PHARMACOPEA # POWDER CONTENT | The for the management of the comments of the comments of the comments of the first and the first and the first and<br> BGPL VALUE | The First of the first of the country of the country of the first of the first of the first of the first of the first of the first of the first of the first of the first of t<br>ASTM REQUIREMENT<br>The Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The program to Apr 1 a Martin Comments of Act A Comments of Act A Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Com | l 150 mg/glove max on Medium size | | 120+/- 20 mg on size 8 | Comment of the consistent of the comments of the production of the comments of the comments of the comments of | # PROTEIN CONTENT: | BGPL VALUE | FDA REQUIREMENT | |---------------|-----------------| | 80 +/- 20 ppm | 200 ppm (max) | # MOISTURE CONTENT: | BGPL VALUE | A BRIDGE CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CON<br>FDA REQUIREMENT | |------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 0.8% max | No value fixed<br>LEL LEARNER BERESS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | # BIOCOMPATIBILITY: | BGPL GLOVE | FDA REQUIREMENT | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Biologically Compatible<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Biologically Compatible | Image /page/2/Picture/11 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the outer edge. Inside the circle, the word "NAGERCOIL" is printed in bold, uppercase letters. The stamp appears to be slightly smudged, giving it a worn or used look. {3}------------------------------------------------ # 8.0. Performance Data: The performance test data of the powdered surgical gloves manufactured by Brightway Gloves Pvt.Ltd is given below. | Measured Parameters of Latex | | | |----------------------------------|------|------------| | Surgeon's gloves (Powdered) | | | | manufactured by Brightway Gloves | | | | Pvt.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/7 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the border. In the center of the stamp is the word "NAGERCOIL" in a bold, sans-serif font. The stamp appears to be somewhat faded or worn, giving it a vintage look. {4}------------------------------------------------ # PERFORMANCE REQUIREMENT: | Characteristics | Related<br>defects | LEVEL | AQL | |-----------------------|-------------------------------------------------------------------------------|--------------------------------|-----| | Sterility | Fails sterility | As per Indian<br>Pharmacopeias | | | Freedom from<br>Holes | Holes | S4 | 1.5 | | Dimension | Width ,<br>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 mg per Glove PROTEIN CONTENT: 80 +/- 20 ppm MOISTURE CONTENT: 0.8 % max BIOCOMPATABILITY: Biologically Compatible 。 9. Clinical Data NA 10. CONCLUSION OF PERFORMANCE TEST DATA: The Powdered Surgeon's gloves manufactured by Brightway Gloves Pvt Ltd - -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/16 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the outer edge. Inside the circle is the word "NAGERCOIL" in a smaller circle. There is a star at the bottom of the stamp. {5}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. N. Paramasivan Managing Director Brightway Gloves PVT. LTD. Pioneer Manikandan Buildings Vadasery, Nagar Coil Tamil Nadu. INDIA 629001 Re: K014278 Trade/Device Name: Sterile Latex Surgeon's Glove, Powdered Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: March 23, 2002 Received: April 11, 2002 Dear Mr. Paramasivan: 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. {6}------------------------------------------------ Page 2 -- Mr. Paramasivan 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 ail 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 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Runge 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}------------------------------------------------ #### PAGE NO : 3 #### INDICATIONS FOR USE: 3.0 BRIGHTWAY GLOVES PVT.LTD. APPLICANT . Ko14278 : 510(K) No. LATEX SURGEON'S GLOVE POWDERED DEVICE NAME INDICATIONS FOR USE: Surgeon's glove (powdered) is a sterile medical device made of natural latex intended to be worn by operating room personnel to protect a surgical wound from contamination and is powdered with absorbable dusting powder USP corn starch as the donning lubricant. Sunge (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 8014279 Image /page/7/Picture/7 description: The image is a circular stamp with the words "OR HIGHWAY GLOVES PVT. LTD." around the perimeter of the circle. Inside the circle is the word "HAGERCOIL" in block letters. The stamp appears to be slightly faded or worn, giving it a vintage look. The text is all in uppercase.