(69 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Patient Examination Glove, Nitrile, Powdered, Turquoise
This submission is for a medical device called an "Omni Flex Nitrile Examination Glove, Powdered, Turquoise." The provided documents are a 510(k) clearance letter and an "Indications For Use Statement." These documents do not contain information about acceptance criteria or performance studies as typically required for clinical software or diagnostic devices.
Instead, they address the regulatory clearance of a physical medical device (gloves) based on substantial equivalence to a predicate device already on the market. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not applicable or available in these documents.
Here's an attempt to address the points based only on the provided text, recognizing its limitations for this type of query:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given documents. The 510(k) clearance process for general-purpose medical gloves typically involves demonstrating substantial equivalence to a legally marketed predicate device through performance criteria such as:
- Physical Properties: Tensile strength, elongation at break, force at break (often specified in ASTM D6319 or similar standards).
- Barrier Integrity: Water leak test (AQL, Acceptable Quality Level, often 2.5 or 4.0 for medical gloves).
- Biocompatibility: Tests for skin irritation and sensitization.
- Powder Residue (if powdered).
However, the specific quantitative acceptance criteria and the Omni Flex Nitrile Examination Glove's performance against these criteria are not detailed in the provided regulatory letter or indications for use. The letter simply states that the FDA has determined the device is "substantially equivalent" to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given documents. For a 510(k) submission for gloves, the "test set" would refer to the samples of gloves tested for physical and barrier properties. The letter indicates the manufacturer is OmniGrace (Thailand) LTD., located in Thailand, suggesting the testing data would likely originate from Thailand or a designated testing facility. The nature of these tests is usually prospective, as manufactured batches are tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device and submission. "Ground truth" in the context of diagnostic devices often refers to an expert-validated diagnosis or pathology result. For medical gloves, the "ground truth" is typically defined by adherence to established material standards and performance specifications, not expert consensus on an image or diagnosis. Quality control personnel and material science engineers would be involved in testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this type of device and submission. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images), which is not relevant to testing the physical properties of gloves.
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
This is not applicable to this type of device and submission. MRMC studies are used for evaluating the performance of diagnostic imaging devices or AI algorithms that assist human readers. Medical gloves are barrier devices, not diagnostic or AI-assisted tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this type of device and submission. This refers to the evaluation of AI algorithms, which is not relevant to medical gloves.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the concept of "ground truth" in the diagnostic or AI sense does not apply here. For medical gloves, the "truth" is established by measured physical properties (e.g., tensile strength, barrier integrity) meeting predefined standards (e.g., ASTM standards, AQL limits) and biocompatibility test results.
8. The sample size for the training set
This is not applicable to this type of device and submission. Training sets are used in machine learning.
9. How the ground truth for the training set was established
This is not applicable to this type of device and submission.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -5 1999
K.C. Choong Vice President of Manufacturing OmniGrace (Thailand) LTD. 641 Moo 5 Kanchanawanit Road Tambon Banpru Hatyai, Songkhla Thailand 90250
Re : K991846 Patient Examination Glove, Nitrile, Trade Name: Powdered, Turquoise Regulatory Class: I Product Code: LZA Dated: May 28, 1999 Received: May 28, 1999
Dear K.C. Choong:
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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action.
{1}------------------------------------------------
Page 2 - K.C. Choong
In addition, FDA may publish further announcements concerning your device in the Federal Register.
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation (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" (21 CFR 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
OMNIGRACE (THAILAND) LTD. 641 MOO 5 KANCHANAWANIT ROAD TAMBON BANPRU HATYAI SONGKHLA THAILAND 90250 TEL: (6674) 439 526 FAX: (6674) 210 600
. ・・ー
14:53
if
ﻳﺘﻬﺎﻳﺔ ﺇﻧ
: «
ﺎ ﺗ なか : :
."
. 1 .. ・ : . . '
・・ ::
ਿੰਦਾ ਦਾ ਵਾਲਾ ਸੀ, ਅਤੇ 'ਤੇ
: - -
な
May 1999 Attachment II
OmniGrace (Thailand) Ltd. 510(k) Premarket Notification Patient Examination Glove, Nitrile, Powdered, Turquoise
INDICATIONS FOR USE STATEMENT
Applicant : OmniGrace (Thailand) Ltd. 510(k) Number : Device Name : Omni Flex Nitrile Examination Glove, Powdered, Turquoise
Indications For Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
| Prescription UsePer 21 CFR 801.109 | OR | Over-The-Counter X |
|---|---|---|
| ---------------------------------------- | ---- | -------------------------------------------------------------------- |
Chin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control,
(5) a Hospital Devices5 : .
§ 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.