(217 days)
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Not Found
No
The 510(k) summary describes a latex examination glove and its performance in skin irritation and sensitization tests. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
No.
The device's intended use is to prevent contamination between healthcare personnel and the patient, which classifies it as a barrier device for infection control, not for treating a disease or condition.
No
This device is a patient examination glove, intended to prevent contamination between healthcare personnel and the patient. Its described function is protective, not diagnostic.
No
The device is a physical glove, not a software application. The description clearly outlines a latex glove and its physical properties and testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment. This is a barrier function, not a diagnostic test performed in vitro (outside the body) on specimens.
- Device Description: The device is a glove, which is a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
- Performance Studies: The performance studies focus on skin irritation and sensitization, which are relevant to a barrier device worn on the skin, not an IVD.
IVDs are devices used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A glove is wom on the hand of healtcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment
Product codes
80LYY
Device Description
Latex Patient Examination glove (Hypoallergenic) 50 micrograms or less of total water extractable protein per gram of glove
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare and similar personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Human Repeat Insult Patch Test: Concordia Research Laboratories, Inc. Study Number. SAT-001 A N/E. Conclusion: "From the complete lack of reactions noted during the Elicitation Phases (Challenge) of this test, it is evident that the irritation and allergenic potential of the test article is extremely low, If existent at all It is the opinion of the undersigned that this product can be safely distributed for its intended use"
Primary Dermal Irritation in Rahbits Guinea Pig Sensitization (Buehler): Consumer Product Testing Co. Experiment reference number T95-0189-1. Conclusion: "According to Federal Hazardous Substances Act Regulations, (16 CFR 1500.41), and under the conditions of this test, this test article is not a primary dermal irritant".
Key Metrics
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K# 960942
Siam Sempermed Corporation. Ltd
510(k) SUMMARY
Page 1 of 2
07.02.1996
1.0 APPLICANT:
Dr. POONSUK CHERDKIATGUMCHAI SIAM SEMPERMED CORPORATION.,Ltd 110 MOO 8 KANJANAVANIT ROAD PATHONG HATYAI SONGKHLA THAILAND 90230 TEL: 66 074 291 648 OR 291 649 FAX: 66 074 291 650
2.0 CONTACT PERSON
Dr. POONSUK CHERDKIATGUMCHAI SIAM SEMPERMED CORPORATION.,Ltd 110 MOO 8 KANJANAVANIT ROAD PATHONG HATYAI SONGKHLA THAILAND 90230 TEL: 66 074 291 648 OR 291 649 FAX: 66 074 291 650
MR DON MORRIS SATARI CORP.,Ltd 14 LEEWARD ISLAND CLEARWATER USA FL 34630 TEL: 813 446 3535 OR 800 366 9545 FAX: 813 443 348
3.0 Device Class: I Product code: 80LYY
4.0 Specification: Class I Latex patient examination glove (Hypoallergenic)-801.Y Y meets all of the requirements of ASTM standard D3578-95
5.0 Device Description: Latex Patient Examination glove (Hypoallergenic) 50 micrograms or less of total water extractable protein per gram of glove
6.0 Intended use: A glove is wom on the hand of healtcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment
7.0 Outer surface: Free from talc (Magnesium silicate)
8.0 Human Repeat Insult Patch Test: Concordia Research Laboratories, Inc. Study Number. SAT-001 A N/E * From the complete lack of reactions noted during the Elicitation Phases (Challenge) of this test, it is evident that the irritation and allergenic potential of the test article is extremely low, If existent at all It is the opinion of the undersigned that this product can be safely distributed for its intended use"
Primary Dermal Irritation in Rahhits Guinea Pig Sensitization (Buehler): Consumer Product Testing Co. Experiment reference number T95-0189-1.
"According to Federal Hazardous Substances Act Regulations, (16 CFR 1500.41), and under the conditions of this test, this test article is not a primary dermal irritant".
This document and its contents are confidential. Do not discuss with or give access to people not designated.
1
.
510(k) SUMMARY
07.02.1996
9.0 QUALITY CHARACTERISTICS
| DESCRIPTION | ASTM standard | SPECIFICATION |
|---|---|---|
| DIMENSION | S-2 AQL 4.0 | S-2 AQL 4.0 |
| Overall length | 230 min. | 240+/-10 mm |
| Width | ||
| (double wall) | S 80 +/- 10 mm | |
| M 95 +/- 10 mm | ||
| L 111 +/- 10 mm | SS 77 +/- 5 mm | |
| S 83 +/- 5 mm | ||
| M 94 +/- 5 mm | ||
| L 105 +/- 4 mm | ||
| Thickness, mm | ||
| Finger | 0.08 mm MIN. | 0.08 mm MIN. |
| palm | 0.08 mm MIN. | 0.08 mm MIN. |
| PHYSICAL PROPERTIES | S-2 AQL 4.0 | S-2 AQL 4.0 |
| Before aging | ||
| Tensile strength | 14 Mpa MIN. | 14 Mpa MIN. |
| Elongation at break | 700 % MIN. | 700% MIN. |
| After aging | ||
| Tensile strength | 14 Mpa MIN. | 14 Mpa MIN. |
| Elongation at break | 500 % MIN. | 500% MIN. |
| WATER EXTRACTABLE | ||
| PROTEIN | N/A | S-2 AQL 4.0 |
| 50 ug/g MAX. | ||
| POWDER LEVEL | N/A | 2.5 +/- 1.0 by weight |
| FREEDOM FROM HOLE | S-4 AQL 4.0 | II AQL 1.5 |
- Conclusion: Siam Sempermed Latex Patient Examination Glove (Hypoallergenic) meet or exceed the ASTM standard or equivalent standard meet pinhole FDA réquirements meet labeling claims (see 5.0 and 6.0 above)
P. Cherdkictgumchai
Dr. POONSUK CHERDKIATGUMCHAI Senior Assistant Chief Production Officer (quality)
This document and its contents are confidential. Do not discuss with or give access to people not designated.