(22 days)
Not Found
Not Found
No
The device is a standard patient examination glove and the summary describes physical and performance characteristics, not AI/ML capabilities.
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, which is a barrier device intended to prevent contamination. It does not perform any diagnostic function.
No
The device description clearly states it is a Class 1 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 clearly states the device is a "patient examination glove" worn on the hand to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM, FDA water leak test, powder content, protein content, biocompatibility). These are related to the glove's performance as a barrier and its safety for use, not its ability to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition. IVDs are designed to perform tests on biological samples to aid in diagnosis, monitoring, or screening.
The information provided describes a medical device used for protection and hygiene, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes, that is worn on A patient cxammation grove is a crevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water leak test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
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
Not Found
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 1000ml watertight test.
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
K98 3608
Image /page/0/Picture/2 description: The image shows a black and white drawing of an object that appears to be a stylized representation of a stool or altar. It has a rectangular base with three vertical supports, and a crescent-shaped object rests on top of the supports. The overall design is simple and symmetrical, with a focus on geometric shapes.
YTY INDUSTRY (MANJUNG) SDN. BHD.
Company No : 380830-P) t 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Tel : 05-6792288 (Hunting Line), 6792443 & 6792445 Fax : 05-6791188
ATTACHMENT N
SMDA 510 (K) SUMMARY 1.0 YTY Industry Sdn Bhd 2.0 Submitter Lot 1422-1424, Batu 10 Lekir 32020 Sitiawan Perak Darul Ridzuan MALAYSIA 605-6792288 Tel 605-6791188 Fax 1. MR. MOH UNG NANG Name of Contact Person September 25, 1998 Date of Summary Prepared 3.0 Name of Device Trade Name : Evergreen Non-Sterile 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 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA requirements.
ﺎ
Description of The Device 5.0
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water leak test.
The Intended Use of Glove 6.0
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Page 1 of 3
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7. Summary of Performance Data :
Performance data of gloves based on ASTM D3578-95 and FDA 1000ml watertight test.
| TEST | ASTM D3578-95 | | EVERGREEN POWDER FREE
LATEX EXAMINATION GLOVES | |
|------------------------------------------|-------------------|-------------|---------------------------------------------------|----------|
| 1. Watertight (1000ml) | G II | | 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. Thicknes (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) | | | 23.8-25.2 | |
| Ultimete Elongation (%) | min 14
min 700 | | 810-910 | |
| After Ageing | | | | |
| Tensile Strength (Mpa) | | | 19.8-20.7 | |
| Ultimete Elongation (%) | min 14
min 500 | | 750-870 | |
| 6. Powder Content | - | | below 2 mg/ glove | |
| 7. Protein content | - | | below 50 microgram/ gram | |
ATTACHMENT N Page 2 Of 3
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The performance data of the glove as shown above meet the ASTM D3578-95 8. 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