(4 days)
Not Found
No
The device description and intended use clearly define a standard examination glove, with no mention of AI or ML capabilities.
No.
A patient examination glove is intended to prevent contamination between a patient and an examiner, which falls under diagnostic or preventative use, not therapeutic.
No
Thisdevice is a patient examination glove, which is a barrier device intended to prevent contamination between a patient and an examiner. It does not perform any diagnostic function.
No
The device is a physical examination glove, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the examiner's hand. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a physical glove with coatings and additives, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely protective and preventative through a physical barrier.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E, and protein claim (50 micrograms or less).
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
Not Found
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.
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
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
K024121
510 (k) Summary As Required by 21 section 807.92 ( c)
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Submitter Name: Siam Sempermed Corp., Ltd
-
Address: 110 Moo 8 Kanjanavanit Road. Pathong Hatyai
- Songkhia. Thailand 90230 3. Phone: (++66) 074 291 648
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- Fax: (++66) 074 291 650
-
- Contract Person: Dr. Poonsuk Cherdkiatgumchai (Chief Quality Officer)
-
- Date summary prepared: October 29, 2002
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- Official Correspondent: Sempermed USA Inc.
- 30798 US Hwy. 19N 8. Address: .
Palm Harbor, USA , FL 34684
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- Phone: 727 787 7250
- 727 787 7558 10. Fax:
-
- Contact person: Mr. William E Harris
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- Device Trade or Proprietary Name: Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E and protein claim (50 micrograms or less).
- Device Common or usual name: Examination glove
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- Device Classification Name: Glove , Patient Examination , Latex
-
- Substantial Equivalency is claimed against the following device :
Siam Sempermed Latex Patient Examination Glove, Powder free, 510(k) #K970794 (refer to Appendix 1 for FDA website printout.
This notification for the non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E, and protein claim (50 micrograms or less) is of the ABBREVIATED type as per the declaration of conformity on page 4 of this summary.
-
- Description of the Device:
Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E, and protein claim (50 micrograms or less).
- Description of the Device:
-
- Intended use of the device:
This device is a disposable device intended for medical purpose that is worn on the examiner 's hand to prevent contamination between patient and examiner
- Intended use of the device:
-
- Safety and effectiveness of the device:
This device is safe and effective as the predicate device Siam Sempermed Latex Examination Glove , Powder free. Indeed , it is equivalent
- Safety and effectiveness of the device:
This is better expressed in the tabulated comparison (Paragraph 19 below)
-
- Summary comparing technological characteristics with other predicate device:
General comparison result between non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E, and protein claim (50 micrograms or less) and predicate device (Siam Sempermed Latex Examination Glove, Powder Free) is tabulated below.
- Summary comparing technological characteristics with other predicate device:
3.1
This document and its contents are confidential. Do not discuss with or give access to people not designated.
1
KC2 4/21
Technical comparison of specific elements is attached in the main submission.
| FDA file reference number | 510k number: K970794 |
|---|---|
| Attachments inside notification | |
| submission file | REFER TO APPENDIX 1 |
| TECHNOLOGICAL | |
| CHARACTERISTICS | Comparison result |
| REFER TO ADDITIONAL TECHNICAL | |
| COMPARATIVE TABLE WITHIN 510K | |
| SUBMISSION | |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Identical |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical (Not applicable) |
| Compatibility with environment | |
| and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |
.
This document and its contents are confidential. Do not discuss with or give access to people not designated.
· · · ·
ું. ર
Image /page/1/Picture/5 description: The image contains the word "CONFIDENTIAL" in large, bold, black letters. The letters are tightly spaced and fill most of the frame. The word appears to be a stamp or a label, indicating the sensitive nature of the document or information it is associated with.
. - - - -------
ﺪ ﺳﻴﺪ .. ..
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a flowing, abstract manner.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
·Siam Sempermed Corporation Limited C/O Mr. Ned Devine, Jr. Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K024121
Trade/Device Name: Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating, Aloe, Vitamin E and Protein Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: October 29, 2002 Received: December 16, 2002
Dear Mr. Devine
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.
3
Page 2 - Mr. Devine
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 all 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), 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulstowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DICATIONS FOR USE
Siam Sempermed Corp., Ltd. Applicant: _
Ko24121 510(k) Number: __
Device Name: Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E, and protein claim (50 micrograms or less).
Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
AB. Jay. Clin
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K024121