(57 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Disposable Powder Free Vinyl Exam Glove, Blue Color
The provided text is a 510(k) premarket notification letter from the FDA regarding a Disposable Powder Free Vinyl Exam Glove, Blue Color. This document is for a Class I medical device and describes its intended use and regulatory classification.
The information requested in the prompt, such as acceptance criteria, details of a study with sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, are typically associated with performance validation of more complex devices, particularly those involving algorithms, diagnostics, or therapeutic effects.
This document does not contain the type of detailed performance study information requested.
Here's why and what can be extracted:
- Device Type: Exam gloves are Class I devices, meaning they pose the lowest risk to patients and users. Their substantial equivalence is typically demonstrated through compliance with recognized standards (e.g., for strength, leak resistance, biocompatibility) rather than complex comparative effectiveness studies or algorithm performance evaluations.
- Regulatory Focus: The FDA letter primarily confirms "substantial equivalence" to a legally marketed predicate device, allowing the introduction of the device to the market under general controls. It's about regulatory clearance, not detailed performance validation in the way one would see for an AI-powered diagnostic tool.
Therefore, I cannot populate the table or answer most of the questions using only the provided text.
However, I can extract the following limited information relevant to the prompt:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document implies that the acceptance criteria for this device are its substantial equivalence to a legally marketed predicate device, as well as compliance with general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration). Specific performance metrics (e.g., tensile strength, barrier integrity) would be part of the underlying submission that led to this letter, but are not detailed here.
- Reported Device Performance: The letter states the FDA "determined the device is substantially equivalent," meaning it met the necessary criteria for regulatory clearance. Again, specific performance metrics are not listed in this public face page.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial Equivalence to Predicate | Determined to be substantially equivalent. |
| Compliance with general controls | Assumed to be met for clearance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated in this document. For a Class I device like gloves, testing typically involves standardized material and physical property tests, not clinical "test sets" in the diagnostic sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. This type of information is usually relevant for diagnostic devices that require expert interpretation or consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not stated.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for this type of device based on the document. Ground truth for gloves usually revolves around manufacturing standards and material properties (e.g., results of leak tests, tensile strength tests, biocompatibility tests).
8. The sample size for the training set:
- Not applicable/Not stated.
9. How the ground truth for the training set was established:
- Not applicable/Not stated.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Full Synergy Medical Products, Incorporated C/O Ms. Elizabeth Deng 5748 Eaglewood Place Rancho Cucamonga, California 91739
FEB 1 4 2012
Re: K113722
Trade/Device Name: Disposable Powder Free Vinyl Exam Glove, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 30, 2011 Received: December 19, 2011
Dear Ms. Deng:
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.
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Page 2 - Ms. Deng
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
G In Anthony Divotson
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
FULL SYNERGY MEDICAL PRODUCTS INC. Applicant:
K 113722 510{k} Number (if known): APPLIED
Device Name: Disposable Powder Free Vinyl Exam Glove, Blue Color
Indications for Use:
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
VOR Over-The
(21 CFR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
11
Sura Renner
(Division Sign-Off) (Division Sign-on)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of Antoot, Dental Devices
510(k) Number: K113722
§ 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.