(10 days)
Not Found
Not Found
No
The summary describes a standard medical glove and provides performance data based on physical properties and standard tests, with no mention of AI or ML.
No
The device, a patient examination glove, is intended to prevent contamination and is not described as having any therapeutic function.
No
Explanation: The device is a medical glove, described as a barrier to prevent contamination, not for diagnosing conditions. Its performance metrics relate to physical properties and safety (e.g., watertight, tensile strength, biocompatibility), not diagnostic accuracy.
No
The device description clearly states it is a "Class I Latex 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 "medical glove worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics and standards met by the glove (latex, powder-free, ASTM standards, FDA water leak test). This aligns with a medical device used for physical protection.
- Performance Studies and Key Metrics: The performance data and key metrics provided relate to the physical integrity and properties of the glove (watertightness, dimensions, thickness, tensile strength, elongation, powder content, protein content, biocompatibility). These are relevant to the function of a protective barrier, not to diagnostic testing.
- Lack of IVD Indicators: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information.
Therefore, this device is a medical glove intended for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or enviroment
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Class I Latex Patient Examination Glove 80 LYY, powder free that meets all of the requirements of ASTM Standard D3578-95 and FDA Water leak test.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data of gloves based on ASTM D3578-95 and FDA 1000 ml watertight test.
Key results include:
- Watertight (1000ml): Pass G II AQL= 4.0 %
- Length (mm): 240 mm minimum for all sizes
- Palm width (mm): Varies by size (XS: 73 - 78, S: 83 - 88, M: 93 - 98, L: 103 - 107)
- Thickness (mm) (Single Layer): Finger min 0.10, Palm min 0.10
- Physical Properties Before Ageing: Tensile Strength 26.5 Mpa, Ultimate Elongation 810 %
- Physical Properties After Ageing: Tensile Strength 22.3 Mpa, Ultimate Elongation 750 %
- Powder Content: below 2 mg / glove
- Protein Content: below 50 microgram / gram
The performance data of the glove as shown above meet the ASTM D3578-95 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements. The protein content tested on accelerated aging gloves is
§ 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
INDUSTRY (MANJUNG) SON. BH
any No : 380830-P
Company No . Socorry Lot 1422-1424, Balu 10 Lokir, 02020 Ghildhan, Freiz : 05-678111
510 (K) SUMMARY
YTY Industry (Manjung) Sdn Bhd Submitter Lot 1422-1424 , Batu 10 Lekir, 32020 Sitiawan. Perak Darul Ridzuan, MALAYSIA.
605-6792288 Tel
605-6791188 Fax
- MR MOH UNG NANG Name of Contact Person
Date of Summary Prepared September 25, 1997
Name Of Device ... 3.0
1.0
2.0
ﺎ ﻳﻮﻧﻴﻮ ﺍﻟ
Trade Name
Evergreen Non-Sterlie Powder Free Latex Examination Glove -Natural Color Evergreen Non-Sterile Powder Free Latex Examination Glove -Pink Evergreen Non-Sterile Powder Free Latex Examination Glove -Blue
Exam Glove Common Name
.
Patient Examination Glove Classification Name
Identification of The Legally Marketed Devices 4.0
Class I Latex. Patient Examination Glove 80 LYY, powder free that meets all of the requirements of ASTM Standard D3578-95 and FDA requirements.
Description Of The Device 5.0
Class | Latex Patient Examination Glove 80 LYY.powder free that meets all of the requirements of ASTM Standard D3578-95 and FDA Water leak test.
The Intended Use Of Glove 6.0
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or enviroment
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Summary of Performance Data : 7.
ুমু
.. ..
Performance data of gloves based on ASTM D3578-95 and FDA 1000 ml watertight test.
| | TEST | ASTM D3578-95 | EVERGREEN POWDER FREE
LATEX EXAMINATION GLOVE |
|----|----------------------------------|---------------|--------------------------------------------------|
| 1. | Watertight (1000ml) | G II AQL=4.0% | Pass G II AQL= 4.0 % |
| 2. | Length (mm) | | |
| | Size XS | Min 230 | 240 mm minimum for
all sizes |
| | S | Min 230 | |
| | M | Min 230 | |
| | L | Min 230 | |
| | XL | - | |
| 3. | Palm width (mm) | | |
| | Size XS | - | 73 - 78 |
| | S | $80 +- 10$ | 83 - 88 |
| | M | $95 +- 10$ | 93 - 98 |
| | L | $111 +- 10$ | 103 - 107 |
| | XL | | |
| 4. | Thickness (mm)
(Single Layer) | | |
| | Finger | min 0.08 | 0.10 minimum |
| | Palm | min 0.08 | 0.10 minimum |
| 5. | Physical Properties. | | |
| | Before Ageing | | |
| | Tensile Strength (Mpa) | min 14 | 26.5 |
| | Ultimate Elongation (%) | min 700 | 810 |
| | After Ageing | | |
| | Tensile Strength (Mpa) | min 14 | 22.3 |
| | Ultimate Elongation (%) | min 500 | 750 |
| 6. | Powder Content | | below 2 mg / glove |
| 7. | Protein Content | - | below 50 microgram / gram |
3
... ... ...
2
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- The performance data of the glove as shown above meet the ASTM D3578-95 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements. The protein content tested on accelerated aging gloves is