(111 days)
Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) 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.
Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011). PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
The document provided is a 510(k) Premarket Notification Summary for Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored). This type of device is classified as a Class I medical device, which means it is subject to general controls and does not typically require extensive clinical data for market clearance. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored)
Predicate Device: Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd.. K120968.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on established industry standards, specifically ASTM standards for medical examination gloves. The device's performance is compared against these standards and to the predicate device.
| Acceptance Criterion (Standard) | Reported Device Performance (Subject Device) | Result of Comparison to Predicate/Standard |
|---|---|---|
| Dimensions - Length: Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Specific Length Range: | 231-250 mm (Predicate: 232-249mm) | Substantially equivalent |
| Dimensions - Width: Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Specific Width Ranges: | Small 84-87 mm; Medium 94-97 mm; Large 103-107mm; X large 111-114 mm (Predicate: Small 80-90 mm; Medium 90-100mm; Large 100-110mm; X large 110-120 mm) | Substantially equivalent |
| Dimensions - Thickness: Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Specific Thickness: | Finger: 0.08-0.10mm; Palm: 0.08-0.11mm (Predicate: Finger 0.08-0.10mm; Palm: 0.08-0.10mm) | Substantially equivalent |
| Physical Properties - Elongation: (Meets ASTM D5250-06) | Before aging: 330-420%; After aging: 350-410% (Predicate: Before aging: 360-500%; After aging: 350-400%) | Substantially equivalent |
| Physical Properties - Tensile Strength: (Meets ASTM D5250-06) | Not explicitly stated in numerical range for the subject device. Implied to meet ASTM standard. (Predicate: Not explicitly stated in numerical range.) | Substantially equivalent |
| Freedom from Pinholes: Meets 21 CFR 800.20, ASTM D5250-06, ASTM D5151-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011) Holes Inspection Level I, AQL 2.5 (Predicate: Meets • 21 CFR 800.20 • ASTM D5250-06 • ASTM D 5151-06 (Reapproved 2011)) | Substantially equivalent |
| Residual Powder: Meets ASTM D6124-06 (Reaffirmation 2011) | Residual powder mean 0.6mg (Predicate: Residual powder mean 1.7mg) | Substantially equivalent |
| Biocompatibility: Meets ISO 10993-10:2002/Amd.1:2006 (for predicate) / ISO 10993-10 Third Edition 2010-08-01 (for subject device) | Under the conditions of this study, the test article was a non-irritant and non-sensitizer (SKIN IRRITATION DERMAL and SENSITIZATION STUDIES). (Predicate: non-irritant and non-sensitizer for SKIN IRRITATION DERMAL and SENSITIZATION STUDIES.) | Substantially equivalent |
| Materials Used: PVC | PVC | Substantially equivalent |
| Dusting or Donning Powder: PU | PU / Surface Coating Agent | Substantially equivalent |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for pinholes, tensile strength, etc.). However, it refers to compliance with ASTM standards (e.g., D5250, D5151, D6124), which inherently define the statistical sampling plans and methodologies for testing.
- Data Provenance: The tests for the subject device were likely conducted by or for Tangshan Hongyun Plastic Products Co., Ltd. in China, as indicated by the submitter's address. The data is retrospective in the sense that the testing was performed on the manufactured devices to demonstrate compliance with standards and equivalence to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For this type of device (medical examination gloves), the "ground truth" is established by conformity to recognized international and national standards (e.g., ASTM, ISO, 21 CFR) rather than expert consensus on interpretive tasks. Therefore:
- Number of Experts: Not applicable in the sense of medical diagnosticians establishing interpretations. The "expertise" lies in the development and validation of the ASTM and ISO standards themselves, and the accreditation of testing laboratories that perform these physical and chemical evaluations.
- Qualifications of Experts: The experts involved would be those who develop and interpret the ASTM and ISO standards, and the qualified personnel in
testing laboratories (e.g., chemists, material scientists, quality engineers) who perform the required tests according to those standards.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve disagreements among experts. This is not applicable here because the acceptance criteria are based on objective physical and chemical measurements against pre-defined, quantitative standards. The "adjudication" is inherent in the test method specified by the ASTM/ISO standard; if a test result falls outside the specified range, the sample (or batch) fails.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human interpretation of diagnostic images or data (e.g., CAD systems for mammography). This device (examination gloves) does not involve human readers or case interpretation in a diagnostic context. Its effectiveness is based on its physical barrier properties and biocompatibility.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the device. A standalone study typically refers to the performance of an AI algorithm operating independently without human intervention. The device in question is a physical medical device (gloves) and does not involve any AI algorithms.
7. The Type of Ground Truth Used
The "ground truth" for these gloves is defined by:
- Objective Measurement against Standards: The physical and performance characteristics (e.g., dimensions, tensile strength, elongation, freedom from pinholes, residual powder) are compared against the quantitative specifications outlined in ASTM D5250-06, ASTM D5151-06, and ASTM D6124-06.
- Biocompatibility Testing: The "ground truth" for biocompatibility (irritation and sensitization) is established through ISO 10993-10 compliant tests. The outcome of these tests determines if the material is deemed non-irritant and non-sensitizer according to established biological safety criteria.
8. The Sample Size for the Training Set
This question is not applicable. Since the device is a physical medical product and not an AI/ML algorithm or a diagnostic tool, there is no "training set" in the context of machine learning. The manufacturing process is controlled by Good Manufacturing Practices (GMP), and quality control tests (like those mentioned in ASTM standards) are performed on batches of products.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable because, as stated above, 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.