(87 days)
The Blue Nitrile Exam 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 Blue Nitrile Exam 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.
The provided document is a 510(k) summary for "Blue Nitrile Exam Gloves" (K211341). It details the device's technical specifications and comparisons to a predicate device, as well as the results of non-clinical performance testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Item / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility - Skin Sensitization (ISO 10993-10) | Grades less than 1 (no sensitization) | All grades are 0. All animals survived and no abnormal signs were observed. |
| Biocompatibility - Skin Irritation (ISO 10993-10) | Primary irritation index 0-0.4 (Negligible response) | Primary irritation index is 0. Response categorized as negligible. |
| Biocompatibility - Cytotoxicity (ISO 10993-5) | Viability reduced to 70% viability is acceptable) | Viability of 100% test article extract is 86.5%. |
| Residual Powder (ASTM D6124-06) | Powder residue limit of 2.0 mg | 0.03 mg |
| Freedom from Holes (ASTM D5151-06) | Samples: 125 gloves; AQL: 2.5 (ISO 2859); Criterion ≤ 7 gloves for water leakage | No glove water leakage found |
| Dimensions (ASTM D6319-10) | S: width 80±10mm, Length ≥220 mm | |
| M: width 95±10mm, Length ≥230 mm | ||
| L: width 110±10mm, Length ≥230 mm | ||
| XL: width 120±10mm, Length ≥230 mm | ||
| Thickness: Finger ≥0.05 mm, Palm ≥0.05 mm | S: width 83-86 mm, Length 253-266 mm | |
| M: width 96-98 mm, Length 243-262 mm | ||
| L: width 106-110 mm, Length 247-254 mm | ||
| XL: width 112-118 mm, Length 245-252 mm | ||
| Thickness: Finger 0.09-0.11 mm, Palm 0.08-0.11 mm | ||
| Physical Properties - Before Aging (ASTM D6319-10) | Tensile Strength ≥ 14MPa | |
| Ultimate Elongation ≥ 500% | Tensile strength 15.7-17.7 MPa | |
| Ultimate Elongation 532.284% - 552.072% | ||
| Physical Properties - After Accelerated Aging (ASTM D6319-10) | Tensile strength ≥ 14MPa | |
| Ultimate Elongation ≥ 400% | Tensile strength 15.2-17.8 MPa | |
| Ultimate Elongation 525.947% - 548.352% |
2. Sample Size Used for the Test Set and Data Provenance
- Skin Sensitization, Skin Irritation, Cytotoxicity: The document specifies "All animals survived" for irritation/sensitization and mentions "L-929 cells" for cytotoxicity, indicating in vitro and in vivo (animal) testing. Specific sample numbers (of animals or cell cultures) are not explicitly stated.
- Freedom from Holes: 125 gloves.
- Residual Powder, Dimensions, Physical Properties (Tensile Strength, Ultimate Elongation): The sample sizes for these tests are not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin for the test data, nor whether it was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This device is a medical glove. The ground truth for its performance is established through adherence to recognized international standards (ISO, ASTM) and established measurement protocols, not typically through human expert consensus in the way an AI diagnostic tool would be evaluated. Therefore, no human experts were explicitly used to "establish the ground truth" for this type of test set in the conventional sense of clinical interpretation. The "ground truth" is defined by the objective measurement criteria outlined in the standards.
4. Adjudication Method for the Test Set
- Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical image interpretation studies. Since this submission is for a medical glove and relies on standardized non-clinical performance testing, such adjudication methods are not applicable and were not used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This is a non-clinical submission for a medical glove, not an AI-assisted diagnostic device that would involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This is a medical glove, not an algorithm or AI device. The tests performed are standalone in the sense that they assess the glove's physical and biological properties directly, without human interpretation as part of the core performance measurement.
7. Type of Ground Truth Used
- The ground truth for this medical device is based on predefined objective criteria and measurement protocols specified in recognized international standards (ASTM D6124, ASTM D5151, ASTM D6319, ISO 10993-10, ISO 10993-5). It involves physical measurements (dimensions, tensile strength, elongation, powder content, water leakage) and biological assays (cytotoxicity, irritation, sensitization) that have established acceptance limits.
8. Sample Size for the Training Set
- Not applicable. This is a medical glove; there is no "training set" in the context of machine learning or AI models. Its performance is evaluated through manufacturing quality control and specific batch testing against established standards.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
§ 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.