(119 days)
The Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
This is a 510(k) premarket notification for Nitrile Examination Gloves, a Class I reserved medical device. The submission aims to demonstrate substantial equivalence to a predicate device (K171422). The "acceptance criteria" in this context refers to the performance standards and test results that the new device must meet to be considered substantially equivalent to the predicate device and safe/effective for its intended use.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The provided tables (Table2 Device Dimensions Comparison, Table3 Performance Comparison, and Table4 Safety Comparison) effectively serve as a comparison of the proposed device's performance against the predicate device, which inherently defines the "acceptance criteria" for substantial equivalence.
| Acceptance Criteria Category | Specific Criteria (from ASTM standards & Predicate) | Proposed Device Performance | Remark/Conclusion on Meeting Criteria |
|---|---|---|---|
| Dimensions | Length (mm): | ||
| XS: 230 min (Predicate) | 220 min | Analysis 1: Meets ASTM D6319-19 | |
| S: 230 min (Predicate) | 220 min | Analysis 1: Meets ASTM D6319-19 | |
| M: 230 min (Predicate) | 230 min | Meets Predicate & ASTM D6319-19 | |
| L: 230 min (Predicate) | 230 min | Meets Predicate & ASTM D6319-19 | |
| XL: 230 min (Predicate) | 230 min | Meets Predicate & ASTM D6319-19 | |
| Width (mm): | |||
| XS: 75 ±5 (Predicate) | 70 ±10 | Analysis 1: Meets ASTM D6319-19 | |
| S: 85 ±5 (Predicate) | 80 ±10 | Analysis 1: Meets ASTM D6319-19 | |
| M: 95 ±5 (Predicate) | 95 ±10 | Meets Predicate & ASTM D6319-19 | |
| L: 105 ±5 (Predicate) | 110 ±10 | Analysis 1: Meets ASTM D6319-19 | |
| XL: 115 ±5 (Predicate) | 120 ±10 | Analysis 1: Meets ASTM D6319-19 | |
| Thickness (mm): | |||
| Finger: 0.05 min (Predicate) | 0.05 min | SAME (Meets Predicate) | |
| Palm: 0.05 min (Predicate) | 0.05 min | SAME (Meets Predicate) | |
| Physical Properties | Before Aging: | ||
| Tensile Strength: 14MPa, min (ASTM D6319) | 14MPa, min | SAME (Meets ASTM D6319) | |
| Ultimate Elongation: 500% min (ASTM D6319) | 500% min | SAME (Meets ASTM D6319) | |
| After Aging: | |||
| Tensile Strength: 14MPa, min (ASTM D6319) | 14MPa, min | SAME (Meets ASTM D6319) | |
| Ultimate Elongation: 400% min (ASTM D6319) | 400% min | SAME (Meets ASTM D6319) | |
| Overall Compliance with ASTM D6319 | Comply with ASTM D6319 | SAME (Meets ASTM D6319) | |
| Freedom from Holes | Be free from holes in accordance with ASTMD5151 AQL=2.5 | Be free from holes in accordance with ASTMD5151 AQL=2.5 | SAME (Meets ASTM D5151) |
| Powder Content | Meet the requirements of ASTM D6124 (Predicate) | 0.1 (meets ASTM D6124) | SIMILAR (Meets ASTM D6124) |
| Biocompatibility | Irritation: Complies with ISO 10993-10 | Not an irritant | SAME (Meets ISO 10993-10) |
| Sensitization: Complies with ISO 10993-10 | Not a sensitizer | SAME (Meets ISO 10993-10) | |
| Cytotoxicity: Complies with ISO 10993-5 | Did not show potential toxicity to L-929 cells | SIMILAR (Meets ISO 10993-5) | |
| Material | Nitrile | Nitrile | SAME |
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME |
| Colorant | White/Blue/Black/Pink (Predicate) | Blue | Analysis 2: Biocompatibility test confirms safety |
| Expiration Dating | ASTM D7160-16 for medical gloves | Not explicitly stated in tables, but implies compliance in Non-Clinical Tests section. | Assumed to be met via D7160-16. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for Freedom from Holes, Tensile Strength, etc.). It only references compliance with ASTM standards, which would define appropriate sample sizes for those tests.
- Data Provenance: The tests are non-clinical (laboratory tests). The manufacturing location is China (5R MED Instruments (Chengdu) Co., Ltd.). The tests themselves are performed according to international (ISO) and U.S. (ASTM) standards. These are prospective tests, specifically conducted to demonstrate compliance for this device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is not an AI/software device that requires human expert adjudication for ground truth. The "ground truth" for Nitrile Examination Gloves is established by objective, standardized physical and chemical tests defined by international (ISO) and U.S. (ASTM) consensus standards. Therefore, human experts for ground truth establishment in the clinical sense are not applicable here. The experts involved would be the certified laboratory technicians and engineers performing and interpreting the results of the specified standards.
4. Adjudication method for the test set:
Not applicable. As noted above, this device relies on objective, quantifiable physical and chemical tests, not subjective interpretations requiring adjudication.
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 physical medical device (gloves), not an AI-powered diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (gloves).
7. The type of ground truth used:
The ground truth is established by objective, standardized tests defined by ASTM and ISO standards. These standards provide quantifiable criteria for properties like dimensions, tensile strength, elongation, freedom from holes, powder content, and biocompatibility.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set is involved for this type of device.
In summary, the "study" proving the device meets acceptance criteria consists of a series of non-clinical, laboratory-based tests conducted in accordance with recognized industry standards (ASTM D6124, ASTM D5151, ASTM D6319, ASTM D7160, ISO 10993-10, ISO 10993-5). The acceptance criteria are essentially the performance requirements set forth in these standards and demonstrated by the predicate device. The results of these tests (summarized in the tables) indicate that the proposed device performs comparably to the predicate and meets the relevant safety and performance standards.
§ 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.