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510(k) Data Aggregation
(58 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
This document is a 510(k) Premarket Notification summary for Powder Free Nitrile Patient Examination Gloves, Blue Color. It does not describe an AI medical device or a study involving human readers. Therefore, I cannot provide details on acceptance criteria or an AI-related study as described in your request.
The provided text details the submission of a medical device (nitrile examination gloves) for regulatory clearance. The core of the submission, and the content of the "Acceptance Criteria" table, relates to physical and chemical properties of the gloves, and biocompatibility, as tested against established ASTM and ISO standards.
Here's an analysis of the existing content in relation to your request, highlighting what's present and what's missing:
1. A table of acceptance criteria and the reported device performance
The provided text contains a comprehensive table on page 4 titled "Features & Description" which functions as the acceptance criteria and reported device performance.
| Features & Description | Acceptance Criteria (from Subject Device) | Reported Performance (from Subject Device) |
|---|---|---|
| Dimension - Length | ≥230mm min (from predicate guidance) | 232 mm min for all sizes |
| Dimension - Width | Small 75-90 mm, Medium 87-102 mm, Large 107-119mm, X large 114-128 mm | Measured values for each size fall within these ranges (implied by "Similar" and comparison to predicate values) |
| Dimension - Thickness | Fingertip ≥0.08mm min, Palm ≥0.08mm min | Fingertip 0.08mm min, Palm 0.08mm min (reported as "Similar" to predicate which implies meeting criteria) |
| Physical Properties - Tensile strength (Before & After aging) | ≥14MPa | Before Aging: 19-25 MPa; After Aging: 17-23 MPa |
| Physical Properties - Elongation (Before aging) | ≥500% | 560-610 % |
| Physical Properties - Elongation (After aging) | ≥400% | 460-570 % |
| Freedom from Pinholes (Water leakage test) | Inspection Level I, AQL2.5, Accept/Reject criteria of 10/11. 5 noncompliance is allowed. | Meets criteria (implied by "Similar" and no reported failure) |
| Residual Powder | <2mg/glove | Mean: 0.1mg/pcs |
| Biocompatibility - Primary Skin Irritation | Not a primary skin irritant | Passes |
| Biocompatibility - Dermal Sensitization | Not a skin sensitizer | Passes |
| Biocompatibility - Cytotoxicity | Non-cytotoxicity to L-929 cells | Pass |
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 for Test Set: The sample sizes are generally specified by the ASTM and ISO standards referenced. For instance, "Freedom from Pinholes" specifies "Inspection Level I, AQL2.5, and Accept/Reject criteria of 10/11," which implies a specific sampling plan based on lot size. "Residual Powder" states "Checked on 5pcs sub-samples (N=5)."
- Data Provenance: The document does not explicitly state the country of origin of the data itself, but the applicant company (Anhui Powerguard Technology Co., Ltd.) is from China. The tests are "Non-clinical tests" conducted to verify compliance with design specifications. It is a prospective study as the tests are conducted on the new device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a physical product (gloves) and not an AI or diagnostic device that requires expert interpretation for ground truth. The "ground truth" is established by direct physical, chemical, and biological testing according to validated standard protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical product; no human adjudication is involved in the performance testing 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
Not applicable. This is a clearance for a physical medical device (gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm in this submission.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth is established by objective, standardized laboratory tests (e.g., tensile strength testing, water leakage test, chemical analysis for residual powder, in vitro and in vivo biocompatibility assays) as defined by ASTM and ISO standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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