(306 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).
How the device functions: PVC films form a barrier to body fluids and bloodborne Pathogens
Scientific concepts that form the basis for the device 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.
Physical and performance characteristics such as design, materials and physical properties: 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.
{"acceptance_criteria_and_performance": "| Features &
Description | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Result of
Comparison |\n|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|\n| Device Name | Powder Free Vinyl Patient
Examination Gloves, Clear
(Non-colored) | Powder Free Vinyl Patient
Examination Gloves, Clear
(Non-colored) | Same |\n| Product Code | LYZ | LYZ | Same |\n| Size | Small/ Medium/
Large/X large | Small/ Medium/
Large/X large | Substantially
equivalent |\n| Intended Use | Powder free Vinyl Patient
Examination Gloves, Clear(Non-
colored)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. | Powder free Vinyl Patient
Examination Gloves, Clear
(Non-colored) 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. | Substantially
equivalent |\n| Device Description
and Specifications | Meets ASTM D5250-06
(Reapproved 2011) | Meets ASTM D5250 -06
(Reapproved 2011) | Substantially
equivalent |\n| Dimensions
-- Length | Meets ASTM D5250-06
(Reapproved 2011)
≥230mm min. | 230mm min for all sizes | Substantially
equivalent |\n| Dimensions
-- Width (Small) | 80-90 mm | 80-85 mm | Substantially
equivalent |\n| Dimensions
-- Width (Medium) | 90-100mm | 95-97 mm | Substantially
equivalent |\n| Dimensions
-- Width (Large) | 100-110mm | 102-108mm | Substantially
equivalent |\n| Dimensions
-- Width (X-Large) | 110-120 mm | 114-118 mm | Substantially
equivalent |\n| -- Thickness (Finger) | 0.05mm min. | 0.05mm min. | Substantially
equivalent |\n| -- Thickness (Palm) | 0.08mm min. | 0.08mm min. | Substantially
equivalent |\n| Physical Properties (Elongation) | ≥300% | ≥300% | Substantially
equivalent |\n| Physical Properties (Tensile Strength) | ≥14MPa | ≥14MPa | Substantially
equivalent |\n| Freedom from Pinholes | Meets ASTM D5151-06
(Reapproved 2011) and 21 CFR 800.20
Inspection Level 1, AQL 2.5 | Meets ASTM
D5151-06
(Reapproved 2011)
Inspection Level 1, AQL 2.5 | Substantially
equivalent |\n| Residual Powder | Meets ASTM D 6124-06
(Reapproved 2011) | Results generated values below
2mg of residual powder | Substantially
equivalent |\n| Materials used | PVC | PVC | Substantially
equivalent |\n| Dusting or Donning
Powder (substance) | PU | PU | Substantially
equivalent |\n| Dusting or Donning
Powder (name) | PU | Surface Coating Agent | Substantially
equivalent |\n| Performance Data | Meets ASTM D5151-06
(Reapproved 2011)
ASTM D5250-06
(Reapproved 2011)
ASTM D6124-06
(Reapproved 2011) | Meets ASTM D5151-06
(Reapproved 2011)
ASTM D5250-06
(Reapproved 2011)
ASTM D6124-06
(Reapproved 2011) | Substantially
equivalent |\n| Single Patient Use | Single Patient Use | Single Patient Use | Substantially
equivalent |\n| Biocompatibility | SKIN IRRITATION DERMAL
and SENSITIZATION
STUDIES Meets ISO
10993-10 :2002/Amd.1:
2006 | The test article was a non-
irritant or non- sensitizer.
SKIN IRRITATION DERMAL
and SENSITIZATION
STUDIES Meets ISO
10993-10 :2002/Amd.1:2006 | Substantially
equivalent |\n| Labeling | -Powder Free
-Patient Examination Glove
-Single Use Only
- Manufactured For:
- Lot | -Powder Free
-Patient Examination Glove
-Single Use Only - Manufactured For:
- Lot | Substantially
equivalent |\n\nStudy proving device meets acceptance criteria:\nThe information provided is a 510(k) Summary for a medical device (Powder Free Vinyl Patient Examination Gloves). The study described is a nonclinical assessment for substantial equivalence to a predicate device. \n\n2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):\nThe document does not specify a separate "test set" sample size in the conventional sense of a clinical or imaging study. The "testing" refers to nonclinical performance tests conducted to demonstrate compliance with recognized consensus standards (ASTM and ISO). The data provenance is not explicitly stated in terms of country of origin of the data, but the submitter is Decent Plastic Co., Ltd. from China. The study is a nonclinical assessment.\n\n3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):\nThis information is not applicable. The device is a patient examination glove, and the evaluation is based on nonclinical performance testing against established standards, not on expert interpretation of observational data.\n\n4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:\nThis information is not applicable, as there is no traditional "test set" and expert adjudication in the context of this nonclinical assessment.\n\n5. 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:\nThis information is not applicable. The device is a patient examination glove, not an AI diagnostic tool, so an MRMC study is not relevant.\n\n6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:\nThis information is not applicable. The device is a patient examination glove, not an algorithm.\n\n7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):\nThe "ground truth" for this device, in the context of demonstrating substantial equivalence, is compliance with established international and national consensus standards. Specifically, the device was evaluated against:\n* ASTM D5250-06 (Reaffirmation 2011) for physical and performance characteristics.\n* ASTM D5151-06 (Reaffirmation 2011) for freedom from pinholes.\n* ASTM D6124-06 (Reaffirmation 2011) for residual powder.\n* 21 CFR 800.20 for water leak test on pinhole AQL.\n* ISO 10993-10: 2002/Amd. 1:2006(E) for biocompatibility (skin irritation and sensitization studies).\n\n8. The sample size for the training set:\nThis information is not applicable. The device is not an AI algorithm that requires a training set.\n\n9. How the ground truth for the training set was established:\nThis information is not applicable, as the device is not an AI algorithm and does not have a training set.", "additional_information": "The statement explicitly mentions that "Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.""}
§ 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.