(131 days)
Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
The Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) meets all the Nitrile requirements of ASTM Specification D6319-10 Standard Specification for Examination Gloves for Medical Application.
The provided document pertains to a 510(k) premarket notification for "Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)". This is a medical device, and the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than a novel AI/software-based device.
Therefore, many of the requested criteria (e.g., sample size for test set, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, training set details, ground truth for training set) are not applicable to this type of medical glove submission. These criteria are typically relevant for AI/ML-based diagnostic or prognostic devices, clinical decision support systems, or other software as a medical device (SaMD).
However, I can extract the acceptance criteria and device performance as reported in the summary:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Standards (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets standard requirements |
| Physical Properties | ASTM D6319-10 | Meets standard requirements |
| Thickness | ASTM D6319-10 | Meets standard requirements |
| Biocompatibility (Irritation) | ISO 10993-10:2002/Amd 1:2006(E) Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity | Pass (Not a primary skin irritant) |
| Biocompatibility (Sensitization) | ISO 10993-10:2002/Amd 1:2006(E) Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity | Pass (Not a contact sensitizer) |
| Watertight (1000ml) | 21 CFR 800.20 | Pass |
| Residual Powder Test | Below 2mg/glove (Implied acceptance based on predicate) | Passes - Below 2mg/glove |
| Freedom from Holes | 21 CFR 800.20: Gloves Free of Holes at quality level of AQL 1.5 (AQL 2.5 required per standard ASTM D6319-10) | Meets Requirements per 21CFR800.20 |
Additionally, the "Substantial Equivalence Comparison" table provides more detailed performance characteristics, with the acceptance criteria being conformance to ASTM D6319-10 or specific thresholds:
| Characteristic and parameters | Acceptance Criteria (from predicate or ASTM D6319-10 references) | Device Performance (Worldmed Manufacturing Sdn. Bhd.) |
|---|---|---|
| Width (Size Large) | Meets ASTM D6319-10 (e.g., XS - 70 ± 10, S - 80 ± 10, M - 95 ± 10, L - 110 ± 10, XL - 120 ± 10) | Meets ASTM D6319-10 (XS - 70 ± 10, S - 80 ± 10, M - 95 ± 10, L - 110 ± 10, XL-120 ± 10) |
| Overall length | Length ≥ 240mm (Meets ASTM D6319-10) | Length ≥ 240mm |
| Palm thickness | Min 0.05mm (Meets ASTM D6319-10) | Min 0.05mm |
| Finger thickness | Min 0.05mm (Meets ASTM D6319-10) | Min 0.05mm |
| Tensile Strength before aging min. | 14.0 MPa (Meets ASTM D6319-10) | 14.0 MPa |
| Tensile Strength after aging min | 14.0 MPa (Meets ASTM D6319-10) | 14.0 MPa |
| Ultimate elongation before aging min | 500% (Meets ASTM D6319-10) | 500% |
| Ultimate elongation after aging | 400% (Meets ASTM D6319-10) | 400% |
| Meets Biocompatibility | Yes | Yes |
| Skin irritation | Passes | Passes |
| Dermal sensitization | Passes | Passes |
| Residual powder test | Below 2mg/glove (Implied based on predicate) | Passes - Below 2mg/glove |
| Freedom from Holes | AQL 1.5 (as per 21CFR800.20, which is stricter than ASTM D6319-10's AQL 2.5) | AQL 1.5 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each test performed (e.g., for dimensions, physical properties, thickness, biocompatibility, watertightness, or tensile strength tests). The testing is generally understood to be performed on manufactured batches of gloves. The manufacturing facility is in Malaysia. The studies are non-clinical, likely prospective testing of manufactured samples.
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)
Not applicable. This is for a physical medical device (examination gloves), not an AI/software device requiring expert interpretation of results for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is not an AI/software-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by standardized material and performance tests as defined by ASTM D6319-10 and 21 CFR 800.20. For biocompatibility, it refers to the results of standard irritation and sensitization tests.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
Not applicable.
§ 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.