(77 days)
This Surgeon's Glove is a device made of natural rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination
CLINCARE Latex Surgical Gloves are class I powdered surgeon's gloves, powdered with absorbable dusting powder, and meet all the requirements of ASTM D 3577.
The provided text describes the acceptance criteria and performance data for the "CLINCARE Latex Surgical Gloves." This document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577-00 | Meets ASTM D 3577-00 |
| Physical Properties | Meets ASTM D 3577-00, Type I | Meets ASTM D 3577-00, Type I |
| Freedom From Holes | Meets ASTM D 3577-00 | Meets ASTM D 3577-00 |
| Biocompatibility (Primary Skin Irritation in Rabbits) | Passes | Passes |
| Biocompatibility (Guinea Pig Sensitization) | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the tests conducted to meet the ASTM standards or biocompatibility. It only states that the device "meets all the requirements of ASTM D 3577." The data provenance is not explicitly mentioned (e.g., country of origin), but it's related to the manufacturing company, TTK Healthcare, Ltd., which is based in India. The studies appear to be retrospective in the sense that they are validations against established standards, not necessarily new prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The acceptance criteria are based on established ASTM standards, which are developed by expert consensus within the field, but the specific experts involved in the testing of this particular device are not stated.
4. Adjudication Method for the Test Set
This information is not provided. The assessment appears to be a direct comparison against predefined quantitative and qualitative criteria within the ASTM standards and biocompatibility tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images, which is not applicable to surgical gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance evaluation for the surgical gloves described is inherently standalone. The device (surgical glove) is tested directly against physical, mechanical, and biological standards without human interpretation in the loop. There is no "algorithm" involved, but the criteria are objective and assessed against the device's inherent properties.
7. The Type of Ground Truth Used
The ground truth used is based on established industry standards (ASTM D 3577-00) and recognized biocompatibility testing protocols. These standards define the acceptable range or pass/fail criteria for various characteristics of surgical gloves.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. Surgical gloves are physical devices, not machine learning algorithms, so there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for a device like surgical gloves in this context.
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TTK Healthcare Limited Biomed Division 6 Chathedral Road, Chennai - 600 086
1. 510(k) Summary
- TTK Healthcare, Ltd. 2. 1-B/2 MIDC Area Chikalthana, Aurangabad Maharashtra, India 431210
Contact: Ms. Meera Rahatkar Telephone: 91-240-488271 91-240-484863 Fax:
June 25, 2001
| Trade Name: | CLINCARE Latex Surgical Gloves |
|---|---|
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Glove |
- CLINCARE Latex Surgical Gloves are class I powdered surgeon's gloves, powdered with 4. absorbable dusting powder, and meet all the requirements of ASTM D 3577.
- న్. CLINCARE Latex Surgical Gloves are class I powdered surgeon's gloves, powdered with absorbable dusting powder, and meet all the requirements of ASTM D 3577.
-
- CLINCARE Latex Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
-
- CLINCARE latex Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3577-00 |
| Physical Properties | Meets ASTM D 3577-00, Type I |
| Freedom From Holes | Meets ASTM D 3577-00 |
| Biocompatibility | |
| Primary Skin Irritation in Rabbits | Passes |
| Guinea Pig Sensitization | Passes |
-
- The performance test data of the non clinical tests are as mentioned immediately above
-
- Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
-
- It is concluded that the CLINCARE Latex Surgical Gloves are as safe, as effective, and perform as well as the glove performance standards referenced above and therefore meet:
ASTM listed standards, FDA hole requirements, and labeling claims for the product.
-
- This summary will include any other information reasonably deemed necessary by the FDA.
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Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an emblem featuring a stylized image of an eagle or bird with three wing-like shapes, suggesting movement or flight.
SEP 1 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TTK Healthcare Limited C/O Mr. Eli J. Carter Consultant 1219 Little Creek Road Durham, North Carolina 27713
Re: K012067
:
Trade/Device Name: Clincare Latex Surgeon's Glove Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: June 22, 2001 Received: July 2, 2001
Dear Mr. Carter:
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 (1 12), it 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.
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
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Page 2 - Mr. Carter
of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Flor of ally I outhal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and iboms (21 es results in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as be ronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 510(k) Fills letter will and n yourse of substantial equivalence of your device to a promarketed predicated. - I 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- 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 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.gov/cdrh/dsma/dsmamain.html.
Sincere v vours.
St. Patrick
thy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
| Applicant: | TTK Healthcare Limited |
|---|---|
| 510(k) Number: | Not Known K012067 |
| Device Name: | Latex Surgeon's Gloves (POWDERED) |
| Indications for Use: | This Surgeon's Glove is a device made of natural rubber latex 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 DCRH Office of Device Evaluation (ODE)
Chun S. Lim
(Division Sign-Off) Division of Dental, Infection Control, And General Hospital Devices
or
510(k) Number K012067
Prescription Use Per 21 CFR 801.109
Over -the- Counter __
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).