(128 days)
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Powdered Nitrile Examination Gloves
The provided text is a 510(k) Pre-market Notification from the FDA concerning "Powdered Nitrile Examination Gloves." This type of document is a regulatory approval for a medical device that demonstrates substantial equivalence to a legally marketed predicate device.
Crucially, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the way you've outlined for AI/diagnostic devices.
Here's why and what information can be extracted:
- Device Type: Examination gloves are Class I medical devices (Product Code: LZA). For these devices, the regulatory pathway (510(k)) primarily focuses on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already on the market.
- No Performance Study Details: The letter acknowledges the submission and states that the device is "substantially equivalent." It doesn't present technical performance metrics, sensitivity, specificity, or reader studies because these are not typically required for this class of device or at this stage of the 510(k) process for a physical, low-risk product like a glove. The "study" mentioned would have been internal testing by the manufacturer to show the glove meets its intended purpose (e.g., integrity, strength, biocompatibility), but the details of that study are not in this FDA letter.
- "Acceptance Criteria" for a Glove: For gloves, "acceptance criteria" likely refer to standards for tensile strength, elongation, puncture resistance, barrier properties, freedom from holes, and biocompatibility, as outlined in recognized industry standards (e.g., ASTM D6319 for nitrile examination gloves). The letter implies that Supermax Glove Manufacturing Sdn. Bhd. provided data demonstrating compliance with these types of standards in their original 510(k) submission, leading to the substantial equivalence determination.
Therefore, I cannot fill out your requested table and study details based on the provided document.
Here’s an explanation of why each of your requested points cannot be addressed by this document:
- A table of acceptance criteria and the reported device performance: Not present. The letter confirms "substantial equivalence" but doesn't list specific performance metrics.
- Sample size used for the test set and the data provenance: Not present. This information would be in the manufacturer's submission, not the FDA's approval letter.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. This concept (experts establishing ground truth) is more relevant to diagnostic interpretations, not physical product testing for gloves.
- Adjudication method: Not applicable/present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable/present. This is for diagnostic interpretation, not product physical properties.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/present. This is for AI/software, not a physical glove.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/present in this context. For gloves, 'ground truth' would be objective physical and chemical test results based on established standards.
- The sample size for the training set: Not applicable/present. This refers to AI model training.
- How the ground truth for the training set was established: Not applicable/present.
In summary, this document is a regulatory approval for a low-risk medical device (exam gloves) based on substantial equivalence, and it does not contain the detailed performance study information typically required for high-risk diagnostic devices or AI algorithms.
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Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/0/Picture/3 description: The image shows a partial view of a logo or emblem, likely from a government or organizational context. The visible portion features a stylized graphic element consisting of three curved lines or shapes stacked vertically, resembling a stylized representation of a person or symbol. The word "DEPARTMENT" is partially visible along the left edge of the image, oriented vertically.
JUL 22 1998
Mr. Stanley Thai Managing Director Supermax Glove Manufacturing Sdn. Bhd. Lot 42, Putra Industrial Park, Bukit Rahman Putra 47000 Sungai Buloh Selangor Darul Ehsan, MALAYSIA
Re : K980966 Powdered Nitrile Examination Gloveš Trade Name: Requlatory Class: I Product Code: LZA Dated: May 27, 1998 June 3, 1998 Received:
Dear Mr. Thai:
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 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, Druq, and Cosmetic Act (Act). 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 aqainst 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Thai
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin 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 regulation (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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
S. Dutrow for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure ...
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Indications for Use Statement : Include the following or equivalent Indications for Use page. 3.0 The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
Supermax Glove Manufacturing Sdn Bhd Applicant :
Powdered Nitrile Examination Gloves
Indications For Use :
Device Name :
510(k) Number (if known) :
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter X
(Optional Format 1-2-96)
- For a new submission, do NOT fill in the 510(k) number blank,
§ 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.