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The Nitrile Examination Gloves (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

The proposed device, Nitrile Examination Gloves (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.

The proposed device is provided non-sterile. The proposed device is made of Nitrile.

AI/ML Overview

The provided text describes the acceptance criteria and the study results for "Nitrile Examination Gloves (Powder free, Blue)". This is a physical medical device, not a software-driven AI device. Therefore, the specific questions regarding AI-related performance metrics (like sample size for test set/training set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance) are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided tables.

Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance	Comments
Physical Performance (ASTM D6319, D412, D573)
Freedom from Holes (ASTM D5151)	Testing for Freedom from holes	AQL 2.5	No water leakage is inspected from 200 samples	Meets acceptance criteria.
Residual Powder (ASTM D6124)	Determine the powder residue for powder free gloves	< 2.0 mg per glove	Size XS: Average 0.28 mg; Size S: Average 0.31 mg; Size M: Average 0.34 mg; Size L: Average 0.31 mg; Size XL: Average 0.40mg	Meets acceptance criteria.
Tensile Strength (Before Aging)	Physical property characteristics	14 MPa min.	≥ 19MPa	Meets acceptance criteria.
Ultimate Elongation (Before Aging)	Physical property characteristics	500% min.	≥ 500%.	Meets acceptance criteria.
Tensile Strength (After Aging)	Physical property characteristics	14 MPa min.	≥ 18 MPa	Meets acceptance criteria.
Ultimate Elongation (After Aging)	Physical property characteristics	400% min.	≥ 473%.	Meets acceptance criteria.
Physical Dimensions (ASTM D412, D3767)
Length (XS, S)	Physical dimensions specification	220 mm min.	Size XS: ≥ 223 mm; Size S: ≥ 224 mm	Meets acceptance criteria.
Length (M)	Physical dimensions specification	230 mm min.	Size M: ≥ 233 mm	Meets acceptance criteria.
Length (L, XL)	Physical dimensions specification	235 mm min.	Size L: ≥ 236 mm; Size XL: ≥ 236 mm	Meets acceptance criteria.
Width (XS)	Physical dimensions specification	70 ± 10 mm	75 ± 2 (73-77) mm	Meets acceptance criteria.
Width (S)	Physical dimensions specification	80 ± 10 mm	85 ± 2 (85-87) mm	Meets acceptance criteria.
Width (M)	Physical dimensions specification	95 ± 10 mm	95 ± 3 (95-98) mm	Meets acceptance criteria.
Width (L)	Physical dimensions specification	110 ± 10 mm	115 ± 4 (115-119) mm	Meets acceptance criteria.
Width (XL)	Physical dimensions specification	120 ± 10 mm	125 ± 2 (115-117) mm	Meets acceptance criteria.
Cuff Thickness	Physical dimensions specification	≥ 0.05 mm	Size XS, S, M, L, XL: ≥ 0.06 mm	Meets acceptance criteria.
Palm Thickness	Physical dimensions specification	≥ 0.05 mm	Size XS, S, M, L, XL: ≥ 0.07 mm	Meets acceptance criteria.
Finger Thickness	Physical dimensions specification	≥ 0.05 mm	Size XS, S, M, L, XL: ≥ 0.10 mm	Meets acceptance criteria.
Biocompatibility (ISO 10993-5, ISO 10993-10)
Cytotoxicity (ISO 10993-5)	Evaluate the endpoint of Cytotoxicity for biocompatibility	No evidence of cytotoxic potential from the extract.	No evidence of systemic toxicity from the extract.	Meets acceptance criteria.
Irritation (ISO 10993-10)	Evaluate the endpoint of irritant for biocompatibility	No irritation on the skin.	No irritation on the skin.	Meets acceptance criteria.
Sensitization (ISO 10993-10)	Evaluate the endpoint of sensitization for biocompatibility	No evidence of causing delayed dermal contact sensitization.	No evidence of causing delayed dermal contact sensitization in the guinea pig.	Meets acceptance criteria.

Study Information (where applicable based on the provided document):

Sample size used for the test set and the data provenance:
- Freedom from Holes (ASTM D5151): 200 samples were inspected.
- Biocompatibility (ISO 10993-10 for sensitization): Guinea pig was used for sensitization test. The document does not specify the exact number of guinea pigs.
- Data Provenance: The document does not explicitly state the country of origin where the tests were performed or if they were retrospective or prospective studies. The company is based in China.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical and chemical bench tests, not involving expert interpretation of data for ground truth.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a physical device, not an AI or imaging device involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical device.
The type of ground truth used: For physical and chemical tests, the "ground truth" is defined by the technical specifications outlined in the referenced ASTM and ISO standards (e.g., specific tensile strength values, elongation percentages, powder residue limits for ASTM standards, and bio-response criteria for ISO biocompatibility standards).
The sample size for the training set: Not applicable, as this is a physical device.
How the ground truth for the training set was established: Not applicable.

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