(78 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterility of surgical gloves, with no mention of AI or ML.
No
Explanation: The device, a Surgeon's Glove, is intended to protect a surgical wound from contamination, which is a protective barrier function, not a therapeutic treatment of a condition or disease.
No.
The device's intended use is to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device is a physical product (surgical gloves) and not software. The description clearly outlines material, standards, and physical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination by being worn by operating room personnel. This is a barrier function for infection control, not a diagnostic test performed on a sample from the human body.
- Device Description: It's classified as a Class 1 device under 21 CFR 878.4460, which is for Latex Surgical Gloves. This classification is for medical devices used in surgery, not for in vitro diagnostics.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening
The information clearly describes a surgical glove used for protection during surgery, which falls under the category of general medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This device is intended to be used as a single use disposable Sterile Surgical Gloves. 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. Surface powder should be removed prior to undertaking operative procedures in order to minimise the risk of adverse tissue reaction. Contents sterile until package is opened or damaged.
Product codes
KGO
Device Description
Classified by FDA's General and Plastic Surgery Device Panel as Class 1, 21 CFR 878.4460. Latex Surgical Gloves, 79 KGO 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)
Discussion of Non-clinical Tests performed for determination of substantial equivalence are as 7. follows: The standards used for Latex Surgical Gloves production are based on ASTM-D-3577-91. All tests meet requirements of Physical and Dimensional Testing. conducted on gloves, Inspection Level S-2, AQL 2.5. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
Summary prepared on | : Joseph. J. E. Pereira
FITCO Dipped Products Pvt. Ltd.
14 A, Cochin Export Processing Zone,.
Cochin - 682 030, Kerala, INDIA
28th September, 1999 |
|----|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Name of the Device | : Latex Surgical Gloves |
| 3. | Predicate Device Information | : Class 1 Latex Surgical Gloves which meets
the requirements of ASTM D3577-91.
The equivalent device identified in the market is the
Latex Surgical Gloves marketed by Kanam Latex
Industries Pvt. Ltd., INDIA [510K NO. K904972]
under brand name SURGICARE |
| 4. | Device Description | : Classified by FDA's General and Plastic Surgery
Device Panel as
Class 1, 21 CFR 878.4460. Latex Surgical Gloves,
79 KGO 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 Gloves |
| 6. | Comparison to Predicate Devices | : The Latex Surgical Gloves manufactured
by FITCO Dipped Products Pvt. Ltd. is substantially
equivalent in safety and effectiveness to the Sterile
Latex Surgical Gloves marketed by Kanam Latex
Industries Pvt. Ltd. India [510K NO. K904972] |
1
- Discussion of Non-clinical Tests performed for determination of substantial equivalence are as 7. follows:
The standards used for Latex Surgical Gloves production are based on ASTM-D-3577-91. All tests meet requirements of Physical and Dimensional Testing. conducted on gloves, Inspection Level S-2, AQL 2.5.
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, claim and we do not claim our gloves as hypo allergenic on our labels.
FITCO Dipped Products Pvt. Ltd., operates in compliance with FDA's GMPs.
-
- Discussion of Clinical Tests Performed:
Not applicable - there is no hypoallergenic claim.
- Discussion of Clinical Tests Performed:
-
- Conclusions:
The Latex Surgical Gloves manufactured by FITCO Dipped Products Private Limited. conform fully ASTM-D- 3577-91 standards as well as applicable 21 CFR references, and meets FDA's pinhole bio-compatibility requirements and labelling claims as shown by data in our restrictions. 510(k).There are no safetylefficacy 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 our predicate device.
For Fitco Dipped Products Ps
J J E Pereira
Director.
Signature Date : 28th September, 1999
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three wavy lines, representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 1999
Mr. Joseph J.E. Pereira Official Correspondent for Fitco Dipped Products Pvt. Ltd. Plot No. 14 - A Cochin Export Processing Zone Kakkanad, Cochin - 682 030 Kerala, India
Re : K993450 Latex Surgical Gloves , Pre-Powdered Trade Name: Requlatory Class: I Product Code: KGO September 28, 1999 Dated: Received: October 12, 1999
Dear Mr. Pereira:
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 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) requlation (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 requlation 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
3
Page 2 - Mr. Pereira
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to beqin 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,
Harold W. Sharpn
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
Attachment III
Indication for use statement
5 I0 ( K ) Number ( if known ) 993450 : Not known
Device Name
Indications for use
Latex Surgical Gloves , PRE - POWDERED :
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.
Surface powder should be removed prior to undertaking operative procedures in order to minimise the risk of adverse tissue reaction.
Contents sterile until package is opened or damaged.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
ﺎ Over-The-Counter-Use (Optional Format 1-2-96)
Aamy Summy for Chutein
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number .