(29 days)
Class 1 Nitrile Patient Examination Glove 80LZA
Not Found
No
The device is a simple patient examination glove and the description and performance data relate to physical properties and biocompatibility, with no mention of AI or ML.
No
The device is a patient examination glove, intended to prevent contamination, not to treat or cure a disease or condition.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, and does not perform any diagnostic function.
No
The device description clearly states it is a Class 1 Nitrile Patient Examination Glove, which is a physical hardware device. The performance studies and key metrics also relate to the physical properties of the glove.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner." This describes a barrier device used for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description focuses on the material (Nitrile), class (Class 1), and performance standards (ASTM D6319-00a53, FDA Water Leak Test) related to its function as a protective barrier.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies and key metrics are related to the physical properties and barrier function of the glove.
Therefore, this device is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance data of gloves based on ASTM D6319-00a53 and FDA 1000 ml watertight test.
TEST: Watertight (1000 ml), ASTM D6319-00aE3 AQL=2.5%: G I, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: Pass GI
TEST: Length (mm), ASTM D6319-00aE3 AQL=2.5%: Min 230, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: 240 mm minimum for all sizes
TEST: Palm width (mm), Size XS, ASTM D6319-00aE3 AQL=2.5%: 80 +/- 10, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: 85 +/- 3 mm
TEST: Palm width (mm), Size S, ASTM D6319-00aE3 AQL=2.5%: 95 +/- 10, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: 95 +/- 3 mm
TEST: Palm width (mm), Size M, ASTM D6319-00aE3 AQL=2.5%: 111 +/- 10, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: 105 +/- 3 mm
TEST: Palm width (mm), Size L, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: 111 +/- 3 mm
TEST: Palm width (mm), Size XL, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: 120 +/- 3 mm
TEST: Thickness (mm) (Single Layer) Finger, ASTM D6319-00aE3 AQL=2.5%: Min 0.05, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: 0.08 minimum
TEST: Thickness (mm) (Single Layer) Palm, ASTM D6319-00aE3 AQL=2.5%: Min 0.05, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: 0.08 minimum
TEST: Physical Properties Before Aging Tensile Strength (Mpa), ASTM D6319-00aE3 AQL=2.5%: Min 14.0, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: 20.4*
TEST: Physical Properties Before Aging Ultimate Elongation (%), ASTM D6319-00aE3 AQL=2.5%: Min 500, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: 618*
TEST: Physical Properties After Aging Tensile Strength (Mpa), ASTM D6319-00aE3 AQL=2.5%: Min 14.0, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: 21.3*
TEST: Physical Properties After Aging Ultimate Elongation (%), ASTM D6319-00aE3 AQL=2.5%: Min 400, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: 616*
TEST: Powder Content, POLYMER COATED POWDER FREE NITRILE EXAM GLOVES AQL=2.5%: Below 2mg / glove
The performance data of the glove as showed above meet the ASTM D6319-00a" 8. Standard and FDA's requirement.
The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
Key Metrics
Not Found
Predicate Device(s)
Class 1 Nitrile Patient Examination Glove 80LZA
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K042238/si
SEP 1 6 2004
SEAL POLYMER INDUSTRIES BERHAD
Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300
| 1.0 | SMDA 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | SEAL POLYMER INDUSTRIES BERHAD |
| Lot 72706, Jalan Lahat | ||
| Kawasan Perindustrian Bukit Merah | ||
| 31500 Lahat, Perak, Malaysia | ||
| Tel | (60 5) 322 3200 | |
| Fax | (60 5) 322 2300 | |
| Name of Contact Person | Ms. CHUN CHOOI FONG | |
| Date of Summary Prepared | August 13, 2004 | |
| 3.0 | Name of Device | |
| Product Name | Cashmere Polymer Coated Powder Free Nitrile | |
| Examination Gloves (Blue, White, Violet, Pink, | ||
| Green) | ||
| Common Name | Exam Glove | |
| Classification Name | Nitrile Patient Examination Glove |
Identification of the Legally Marketed Devices 4.0
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements.
5.0 Description of The Device
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.
The Intended Use of Glove 6.0
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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Page 1 of 3 ATTACHMENT Q
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SEAL POLYMER INDUSTRIES BERHAD
Lot 72706, Jalan Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 -- 322 2300
Summary of Performance Data: 7.
Performance data of gloves based on ASTM D6319-00a53 and FDA 1000 ml watertight test.
| TEST | ASTM D6319-00aE3
AQL=2.5% | POLYMER COATED POWDER FREE NITRILE EXAM GLOVES
AQL=2.5% | |
|------------------------------------------------------------------|------------------------------|------------------------------------------------------------|--|
| 1. Watertight (1000 ml) | G I | Pass GI | |
| 2. Length (mm)
Size | Min 230 | 240 mm minimum for all sizes | |
| XS | Min 230 | | |
| S | Min 230 | | |
| M | Min 230 | | |
| L | Min 230 | | |
| XL | Min 230 | | |
| 3. Palm width (mm)
Size | - |