(216 days)
Not Found
No
The summary describes a standard examination glove and does not mention any AI or ML capabilities.
No.
This device is an examination glove intended to prevent contamination between patient and examiner, not to treat, cure, mitigate, or prevent disease.
No
The device is a medical glove intended to prevent contamination, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is a "Non-sterile, Powder-free Nitrile Examination Glove," which is a physical hardware component, 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 be worn on the examiner's hand to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The device is described as an examination glove. Examination gloves are considered medical devices, but not IVDs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for a barrier function during medical examinations, which falls under the category of general medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This 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 with Polymer coating, Aloe and Vitamin E. Blue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
Reference Device(s)
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
ATTACHMENT 1
510 (k) Summarv
As Required by 21 section 807.92 (c)
- Submitter Name: Siam Sempermed Corp., Ltd 1.
- 10 Soi 10 Phetkasem Rd. Hatvai 2. Address: Songkhla. Thailand 90110
-
- Phone: (+66) 74 344 663
- (+66) 74 344 677 4. Fax:
Mr. Anan Pruksanusak (Chief Operations Officer) 5. Contract Person:
-
Date summary prepared: December 5, 2012 6.
Official Correspondent: Sempermed USA Inc. 7. -
13900 49th Street North 8. Address: Clearwater, USA , FL 33762
-
727-787-7250 9. Phone:
-
727-787-7558 10. Fax:
-
- Contact person: Mr. William E. Harris, III
-
Device Trade or Proprietary Name: Nitrile Examination Gloves with Aloe & Vitamin E, Powder-Free
-
Device Common or usual name: Examination glove
-
- Device Classification Name: Polymer patient examination glove
-
- Device Class: Class 1
-
Product Code: LZA
-
Description of the Device: Non-sterile, Powder-free Nitrile Examination Glove with Polymer coating, Aloe and Vitamin E. Blue.
18. Intended use of the device:
This is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
19. Predicate devices:
- K083755: Non-Sterile, Powder-Free Nitrile Examination Glove with Polymer Coating. Tested for a. use with Chemotherapy Drugs [core glove].
- K024121: Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating, Aloe, b. Vitamin E and Protein Claim (50 micrograms or Less) [Aloe & Vitamin E coating].
20. Summary of the Technological Characteristics:
Non sterile, Powder free Nitrile Examination Glove with Polymer coating, Aloe, Vitamin E, Blue is substantially equivalent to the predicate devices. A side-by side comparison of the predicate devices with the subject device is presented in Table 1.
1
Table 1. Side-by-side Comparison of Predicate Devices with Subject Device
| Device Description | Predicate 1: K083755 | Predicate 2: K024121 | Subject device | Substantial
Equivalence |
|--------------------------|--------------------------------|--------------------------------------------------|--------------------------------------|----------------------------|
| | Non-Sterile, Powder Free | Non-Sterile, Powder-Free | Non-Sterile, Powder- | |
| | Nitrile Blue Examination | Latex Examination | Free Nitrile Examination | |
| | Glove with Polymer | Gloves with Polymer | Gloves with Polymer | |
| | Coating. Tested for use | Coating, Aloe, Vitamin E | Coating, Aloe and | |
| | with Chemotherapy Drugs | and Protein Claim (50 | Vitamin E, Blue | |
| | [core glove] | micrograms or Less [aloe
& vitamin E coating] | | |
| Intended Use | This is a medical device | This is a medical device | This is a medical device | |
| | intended for medical | intended for medical | intended for medical | |
| | purposes that is worn on | purposes that is worn on | purposes that is worn on | |
| | the examiner's hand to | the examiner's hand to | the examiner's hand to | SE |
| | prevent contamination | prevent contamination | prevent contamination | |
| | between patient and | between patient and | between patient and | |
| | examiner | examiner | examiner | |
| Device Design | A protective garment that | A protective garment that | A protective garment | |
| | covers the hand and wrist | covers the hand and wrist | that covers the hand and | SE |
| | with openings for fingers | with openings for fingers | wrist with openings for | |
| | and thumb | and thumb | fingers and thumb | |
| Primary
Compound Used | Nitrile Synthetic latex | Natural Rubber Latex | Nitrile Synthetic Latex | SE |
| Single Use | Yes | Yes | Yes | SE |
| Ambidextrous | Yes | Yes | Yes | SE |
| Sterility | Not applicable | Not applicable | Not applicable | SE |
| Biocompatibility | Passes Primary Dermal | Passes Primary Dermal | Passes Primary Dermal | |
| | Irritation in Rabbits and | Irritation in Rabbits and | Irritation in Rabbits and | |
| | Guinea Pig Closed Patch | Guinea Pig Closed Patch | Guinea Pig Closed Patch | SE |
| | Sensitization Test (ISO | Sensitization Test (ISO | Sensitization Test (ISO | |
| | 10993-10) | 10993-10) | 10993-10) | |
| Dimensions | Meets ASTM D6319-10 | Meets ASTM D3578-05 | Meets ASTM D6319-10 | SE |
| Tensile Strength | Meets ASTM D6319-10 | Meets ASTM D3578-05 | Meets ASTM D6319-10 | SE |
| Ultimate
Elongation | Meets ASTM D6319-10 | Meets ASTM D3578-05 | Meets ASTM D6319-10 | SE |
| Freedom from
Pinholes | Meets ASTM D5151-6 | Meets ASTM D5151-6 | Meets ASTM D5151-6 | SE |
| Residual Powder | Meets ASTM D6124 | Meets ASTM D6124 | Meets ASTM D6124 | SE |
| Polymer Coating | Yes | Yes | Yes | SE |
| Color | Lavender Blue | Natural | Blue | SE |
| Labeling | Includes chemotherapy
claim | Includes Aloe and
Vitamin E claim | Includes Aloe and
Vitamin E claim | SE |
| Aloe & Vitamin E | No | Yes | Yes. Same proprietary | SE |
19. Conclusion:
The physical performance characteristics of the subject device (Non-Sterile, Powder free Nitrile Examination Glove with Polymer coating, Aloe, and Vitamin E, Blue) is substantially equivalent to predicate K083755 and will perform according to the glove performance standards referenced. Both are manufactured from the same nitrile synthetic latex material using the same production process. The subject device lacks the chemotherapy claim of predicate K083755. Although predicate K024121 is composed of natural rubber latex, it is treated with the same Aloe and Vitamin E coating mixture as the subject device is therefore considered to be substantially equivalent to currently marketed devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of three human figures in profile, stacked on top of each other. The figures are black and have a flowing, abstract design. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 27, 2012
Siam Sempermed Corporation, Limited C/O Mr. William E. Harris President and Chief Executive Officer Sempermed USA. Incorporated 13900 49th Street North CLEARWATER FL 33762
Re: K121549
Trade/Device Name: Nitrile Examination Gloves with Aloe & Vitamin E, Powder-Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 14, 2012 Received: December 20, 2012
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
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 devicerelated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory. Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
ATTACHMENT 6
Indications for Use
510(k) Number (if known): K121549
Device Name: Nitrile Examination Gloves with Aloe & Vitamin E, Powder-Free
Device Description: Non-sterile, Powder-free Nitrile Examination Glove with Polymer Coating, Aloe, and Vitamin E, Blue
Indications For Use:
Indications For Use: This 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)
Maria Cruz-
fisher
Digitally signed by Maria Cruz-fisher DN: c=US, o=U.S. Government, ou=H FDA, OI ople, cn=Mari
0.9 2342.19200300.100.1.1=2000576169 Date: 2012.12.27 10:52:14 -0510
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: