(238 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and material characteristics of a nitrile examination glove, with no mention of AI or ML technologies.
No.
The device is described as a "patient examination glove," intended to prevent contamination between patient and examiner, not to treat a disease or condition.
No
Explanation: A patient examination glove is a medical device intended to prevent contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a "Non sterile, Powder free Nitrile Examination Glove," which is a physical hardware product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "Patient examination glove" worn on the hand to prevent contamination between patient and examiner. This is a barrier device for protection, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical characteristics of the glove (material, color, coating, chemotherapy drug testing). It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There are no mentions of:
- Analyzing samples (blood, urine, tissue, etc.)
- Reagents or assays
- Diagnostic information
- Any of the typical characteristics of an IVD.
This device falls under the category of a medical device, specifically a patient examination glove, as defined by 21 CFR Part 880.6250.
N/A
Intended Use / Indications for Use
Based upon 21 CFR Prt 880.6250: "Patient examination glove." A patient res mination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coated, Tested for use with chemotherapy drugs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The technological characteristics of the device were compared to ASTM or equivalent standards:
- Dimensions: ASTM D 6319-00a-05, Meets
- Physical Properties: ASTM D 6319-00a-05, Meets
- Freedom from pinholes: ASTM D 6319-00a-05, Meets
- Powder Free Residue: ASTM D 6124-06, Meets
- Biocompatibility: Primary Skin Irritation in Rabbits, Passes; Guinea Pig Sensitization, Passes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510 (k) Summary
As Required by 21 section 807.92 (c)
MAY 2 9 2009
- Submitter Name: Siam Sempermed Corp., Ltd 1.
- 352 Kanjanavanit Road. Pahtong Hatyai 2. Address: Songkhla. Thailand 90230
- (+66) 74 291 471 3. Phone:
- (+66) 74 471 337 4. Fax:
Contract Person: Mrs. Parawan Paiyasan(Quality System Manager) ഗ്
Date summary prepared: September 22, 2008 ર.
- Official Correspondent: Sempermed USA Inc.
- 13900 49th Street North 8. Address: Clearwater, USA , FL 33762
- 727 787 7250 9. Phone:
- 727 787 7558 10. Fax:
- Mr. William E. Harris 11. Contact person:
-
Device Trade or Proprietary Name: Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating Tested for use with chemotherapy drugs.
-
Device Common or usual name: Examination glove
-
Device Classification Name: Nitrile Patient Examination Glove (Powder Free(Polymer coated),Blue color)
-
- Description of the Device:
Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coated, Tested for use with chemotherapy drugs.
- Description of the Device:
- Indications for se of the device: Based upon 21 CFR Prt 880.6250: "Patient examination glove." A patient res mination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
17. Summary of The Technological Characteristics of The devices:
amary of Title Technological Characteristics of Trio decised for use with Polymer coated, Tested for use with Non seenle, Fowder Inc. Forme Exammation Over, Story, Free Pological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 6319-00a-05 | Meets |
| Physical Properties | ASTM D 6319-00a-05 | Meets |
| Freedom from pinholes | ASTM D 6319-00a-05 | Meets |
| Powder Free Residue | ASTM D 6124-06 | Meets |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passes |
| Guinea Pig Sensitization | Passes |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siam Sempermed Corporation C/O Mr. William E. Harris President & CEO Sempermed USA, Incorporated 13900 49th Street North Clearwater, Florida 33762
MAY 2 9 2009
Re: K082957
Trade/Device Name: Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer Coating, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May21, 2009 Received: May 26, 2009
Dear Mr. Harris:
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 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.
2
Page 2- Mr. Harris
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Anthony D. Watson for
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Applicant: Siam Sempermed Corp. Ltd.
510(k) Number: K082957
Use
Device Name: Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer Coating, Tested for Use with Chemotherapy Drugs
Indications for : Based upon 21 CFR Part 880.6250; "Patient examination glove" .
A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shiela A. Murphy
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082457 Page 1 of __