(23 days)
Not Found
Not Found
No
The device is a simple examination glove and the description and performance metrics relate to physical properties and biocompatibility, with no mention of AI or ML.
No
The device is a patient examination glove, intended for preventing contamination, not for treating any condition or disease.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to diagnose a condition or disease.
No
The device is a physical patient examination glove, not a software application. The description focuses on material properties and performance tests related to the physical glove.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove...worn on the examiner's hands or finger to prevent contamination between patient and examiner." This is a barrier device used during physical examination, not a device used to examine specimens in vitro (outside of the body).
- Device Description: The description details the material (nitrile), class (Class 1), and standards it meets (ASTM D6319-00a53 and FDA requirements for gloves). These are characteristics of a medical glove, not an IVD.
- Performance Studies and Key Metrics: The performance data and key metrics relate to the physical properties and barrier function of the glove (watertightness, dimensions, thickness, tensile strength, biocompatibility). These are relevant to a protective barrier device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
In summary, the device's purpose is to provide a physical barrier during patient examination, which is a function of a medical device, not 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 (comma separated list FDA assigned to the subject device)
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 / medical purposes
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data of gloves based on ASTM D6319-00a53 and FDA 1000 ml watertight test.
Key results are tabulated under "Summary of Performance Data: 7."
- Watertight (1000 ml): Pass G I (against ASTM D6319-00aE3 AQL=2.5%)
- Length (mm) for all sizes (XS, S, M, L, XL): Min 230 (ASTM) vs 240 mm minimum for all sizes (POWDER FREE NITRILE EXAM GLOVES)
- Palm width (mm) for sizes XS, S, M, L, XL, XXL: Ranging from
§ 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
KOH2101
SEAL POLYMER INDUSTRIES BERHAD Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300
SMDA 510 (K) SUMMARY 1.0 SEAL POLYMER INDUSTRIES BERHAD 2.0 Submitter Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak, Malaysia (60 5) 322 3200 Tel (60 5) 322 2300 Fax Ms. CHUN CHOOl FONG Name of Contact Person Date of Summary Prepared August 2, 2004 Name of Device 3.0 Powder Free Nitrile Examination Gloves Device Name Exam Glove Common Name Nitrile Patient Examination Glove Classification Name
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.
Description of The Device 5.0
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the Cluss T Thirne Fullions Channing of 20-00a53 and FDA Water Leak Test.
6.0 The Intended Use of Glove
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 O
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SEAL POLYMER INDUSTRIES BERHAD
Lot 72706, Jalan Lahat 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% | POWDER FREE NITRILE EXAM
GLOVES
AQL=2.5% |
|----------------------------------------|------------------------------|------------------------------------------------|
| 1. Watertight (1000 ml) | G I | Pass G I |
| 2. Length (mm)
Size | Min 230 | |
| XS | Min 230 | 240 mm minimum for
all sizes |
| S | Min 230 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | Min 230 | |
| 3. Palm width (mm)
Size | - | |
| XS | - |