(64 days)
Not Found
Not Found
No
The device is a surgical glove and the description focuses on material properties and performance standards, with no mention of AI or ML.
No
Therapeutic devices are intended to treat or cure a disease or condition. This device is a surgical glove, which is a barrier for protection and does not have a therapeutic effect.
No
Explanation: The device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device is a surgical glove, which is a physical hardware device made of natural rubber latex. The description focuses on material properties, physical testing, and standards related to gloves, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "single use disposable sterile surgical glove" intended to be worn by operating room personnel to protect a surgical wound from contamination. This is a physical barrier device used on the body, not a device used to examine specimens from the body.
- Device Description: The description classifies it as a Class 1 device under 21 CFR 878.4460, which is for "Surgical Powder-free Latex Gloves." This classification is for medical devices used in surgery, not for diagnostic tests.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening
The information provided describes a standard surgical glove, which is a medical device but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended to be used as a single use disposable sterile surgical glove.
This Surgeon's Glove is a device made of naturel rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Classified by FDA's General and Plastic Surgery Device Panel as Class 1, 21 CFR 878.4460, Surgical Powder-free Latex Gloves, 79KGO and meets all requirements of ASTM standard D-3577-91.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
KEMWELL
Kemwell International Ltd. 3-B, II PHASE, PEENYA BANGALORE 560 058, INDIA PH : 91-80-8395701/8392354 TLX : 845-5078 KIPL IN FAX : 91-80-8391450/8396345
APR - 8 1998
Attachment I
510(k) SUMMARY
This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510 (k) number is :
| 1. Submitter's identification | C ALVA
Kemwell International Ltd.
3-B, Peenya, II Phase
Bangalore 560 058, INDIA. |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary prepared | January 19, 1998 |
| 2. Name of the Device | Coloured Powder-free Latex Surgical
Gloves. |
| 3. Predicate Device Information | Class I powder-free Latex Surgical Gloves
which meets the requirements of ASTM D
3577-91. The equivalent device identified in
the market is SAFESKIN-SUPRA of
Safeskin Corporation, USA(This product is
of natural colour). |
| 4. Device Description | Classified by FDA's General and Plastic
Surgery Device Panel as Class 1, 21 CFR
878.4460, Surgical Powder-free Latex
Gloves, 79KGO and meets all requirements
of ASTM standard D-3577-91. |
| 5. Intended Use | This device is intended to be used as a single
use disposable sterile surgical glove. |
| 6. Comparison to Predicate Devices | Kemwell International Ltd. Powder-free
Latex Surgical Gloves is substantially
equivalent in safety and effectiveness to the
gloves sold by Safeskin Corporation USA,
the brand name SAFESKIN-SUPRA. |
1
KEMWELL
Kemwell International Ltd. 3-B, II PHASE, PEENYA BANGALORE 560 058, INDIA PH : 91-80-8395701/8392354 TLX : 845-5078 KIPLIN FAX : 91-80-8391450/8396345
-
- Discussion of Non-clinical Tests performed for determination of substantial equivalence are as follows:
The standards used for Coloured Powder-free Latex Surgical Gloves production are based on ASTM-D-3577-91. All test meet requirements of Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.
- Discussion of Non-clinical Tests performed for determination of substantial equivalence are as follows:
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 1.5. Inspection Level 1 meeting these requirements. Primary skin Irritation and Skin sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritation or sensitization reactions.
There are no special labelling claims and we do not claim our gloves as hypoallergenic on our labels.
Kemwell International Ltd., operates in compliance with FDA's GMPs.
- Discussion of Clinical Tests Performed:
Not applicable - there is no hypoallergenic claim.
Un
-
- Conclusions:
Kemwell International Ltd. Coloured Powder-free Latex Surgeon's Glove conform fully to ASTM-D-3577-91 standards as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labelling claims as shown by data in our 510 (k). There are no safety/efficacy issues or new claims from the "Substantial equivalence" products cited.
- Conclusions:
Based on the non-clinical tests our product has demonstrated to be as safe as effective as our predicate device.
For Kemwell International Ltd.,
SIGNATURE:
C. ALVA, General Manager (Technical)
DATE:19-1-1998
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 stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 1998
Kemwell International, Ltd. C/O Ms. Susan D. Goldstein-Falk Official Correspondent for Kemwell International Ltd. MDI Consultants 55 Northern Boulevard, Suite 410 Great Neck, New York 11021
Re : K980412 Green Powder-Free Latex Surgical Gloves Trade Name: Regulatory Class: I Product Code: KGo Dated: January 29, 1998 Received: February 3, 1998
Dear Ms. Goldstein-Falk:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਜੋ 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
3
Page 2 - Ms. Goldstein-Falk
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 requlation (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,
Patricia Cucciniello
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| Page | 1 of 1 |
|---|---|
| Attachment III |
| 510(k) Number (if known): | K980412 |
|---|---|
| Device Name: | Green Coloured Powder-free Latex Gloves Surgeon's |
Indications For Use:
This Surgeon's Glove is a device made of naturel 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 CDRH, Office of Device Evaluation (ODE)
| and General Hospital Devices | |
|---|---|
| 510(k) Number | K980412 |
| Prescription Use (Per 21 CFR 801.109) | CR | Over-The-Counter Use | X |
|---|---|---|---|
| --------------------------------------- | ---- | ---------------------- | --- |
(Optional Format 1-2-96)
.
.