(108 days)
A 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.
Latex Examination Gloves, Powdered
Here's a breakdown of the requested information based on the provided FDA 510(k) clearance letter for "Latex Examination Gloves, Powdered":
Important Note: The provided document is an FDA clearance letter, which means the device has already gone through the review process. This letter approves the device based on a previous submission that contained the details of the studies and acceptance criteria. Therefore, the letter itself does not explicitly list the acceptance criteria or the full study details, but rather confirms that the device has met the requirements for substantial equivalence.
To fully answer your request, one would typically need to refer to the original 510(k) submission (K974660). However, based on the nature of this particular device (Latex Examination Gloves), we can infer common acceptance criteria and the type of studies usually conducted for such products.
Inferred Acceptance Criteria and Reported Device Performance (based on common standards for examination gloves):
| Acceptance Criteria (Inferred) | Reported Device Performance (Implied by Clearance) |
|---|---|
| Physical Properties | |
| Tensile Strength (before and after accelerated aging) | Meets relevant ASTM/ISO standards |
| Elongation at Break (before and after accelerated aging) | Meets relevant ASTM/ISO standards |
| Force at Break (before and after accelerated aging) | Meets relevant ASTM/ISO standards |
| Barrier Integrity | |
| Freedom from Holes (AQL Level 2.5 or 4.0 for water leak test) | Meets an Acceptable Quality Limit (AQL) |
| Biocompatibility | |
| Dermal Sensitization | No significant irritation or sensitization observed |
| Primary Skin Irritation | No significant irritation observed |
| Cytotoxicity | Non-cytotoxic |
| Sterility (if applicable - though this is "examination" gloves, often non-sterile by default) | (Not applicable for non-sterile gloves) |
| Powder Content (for powdered gloves) | Meets relevant ASTM/ISO standards for powder residue |
Explanation:
For medical examination gloves, the primary performance characteristics revolve around their physical strength, barrier integrity (preventing fluid/pathogen transfer), and biocompatibility (not causing adverse reactions on the skin). The FDA's 510(k) clearance implies that the device has demonstrated substantial equivalence to a predicate device, which inherently means it has met these types of performance standards.
1. A table of acceptance criteria and the reported device performance:
See table above. The "reported device performance" is implied by the FDA's "substantial equivalence" finding. The actual numbers would be in the original K974660 submission.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the clearance letter. For barrier integrity (Freedom from Holes), AQL (Acceptable Quality Limit) sampling plans are typically used (e.g., ANSI/ASQ Z1.4 for attributes sampling), which dictate sample sizes based on lot size and desired AQL level. For physical properties, standard test methods (e.g., ASTM D412) specify sample numbers (e.g., 5-10 specimens per test). Biocompatibility tests usually involve a small number of animal subjects (e.g., 3-5 for irritation/sensitization).
- Data Provenance: Not specified in the clearance letter. Typically, device manufacturers conduct these tests in their own labs or through accredited contract testing organizations. The country of origin of the data would likely be Malaysia (where Ideal Quality Sdn. Bhd. is located) or another country with accredited testing facilities.
- Retrospective or Prospective: These types of performance and safety tests are prospective studies performed specifically to demonstrate compliance with standards for the 510(k) submission.
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 question is more applicable to diagnostic devices involving image interpretation or complex clinical assessments. For a physical device like examination gloves:
- Ground Truth Establishment: The "ground truth" for gloves is established by objective, standardized test methods designed to measure physical properties (e.g., ISO, ASTM standards). There isn't an "expert" consensus in the same way as in diagnostic AI.
- Experts involved: The "experts" would be the laboratory personnel performing the standardized tests, who are qualified and trained in operating the testing equipment and interpreting results according to the specified standards (e.g., trained technicians, chemists, materials scientists). Their qualifications would include proficiency in the specific ASTM or ISO test methods.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable in the sense of expert consensus for diagnostic tasks. The results of the physical and chemical tests are objective measurements. Any "adjudication" would refer to internal lab quality control processes, where results might be cross-checked or equipment calibrated.
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:
- MRMC Study: Not applicable. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists interpreting images). Examination gloves are physical barrier devices, not diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This concept applies to AI algorithms. Examination gloves do not have an "algorithm" component. Their "performance" is inherently standalone in the sense that their physical characteristics are tested directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For examination gloves, the "ground truth" is derived from:
- Standardized Test Methods: Adherence to established international and national standards (e.g., ASTM D3578 for medical examination gloves, ISO 11193 for single-use medical examination gloves) which define acceptable limits for tensile strength, elongation, freedom from holes, etc.
- Reference Materials/Controls: Use of calibrated equipment and reference materials to ensure accurate measurements.
- Chemical Analysis: For biocompatibility and powder content.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This concept applies to machine learning models that require a 'training set' to learn patterns. Examination gloves are manufactured physical products and do not involve a training set in this context. Their design and manufacturing processes are based on engineering principles and material science, not AI training.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" for physical medical devices like examination gloves. The "ground truth" for ensuring quality and safety in manufacturing is established through adherence to Good Manufacturing Practices (GMP) and ongoing quality control testing against established product specifications.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three flowing lines, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 1998
Mr. Lim Leng Bung Director Ideal Quality Sdn. Bhd. Lot 1365, 17th Miles, Jalan Sungai Sembilang, 45800 Jeram, Selangor Darul Ehsan, MALAYSIA
Re : K974660 Latex Examination Gloves, Powdered Trade Name: Regulatory Class: I Product Code: LYY Dated: March 18, 1998 Received: March 20, 1998
Dear Mr. Lim Leng Bung:
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 The general controls provisions of the Act 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. ਰੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements 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 through 542 of
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Page 2 - Mr. Lim Leng Bunq
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 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 regulation 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.fdalgov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directdr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 3
Page 1 of 1
510 (K) Number (if known) : K974660
Device Name
: Patient Examination Glove, PowDERED
Indications For Use
A 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.
(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 K974660
Prescription Use ( Per 21 CFR 801. 109 ) OR
Over-The-Counter Use X
Section Sams Santa Sant Firmat 1-2-96 )
Sections Santa Sant Properties Institution 14.346 Toti . 1445336. 4687 . FLEHE FISAG SOOKAISK 3.12 13.48
СОРГАНИЯ ОР ПЕННАНАЯН ירושים של המועד המועד સ્ ! ર CARTO PARTICITAXO KETAS
§ 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.