(186 days)
Not Found
Not Found
No
The device description and intended use clearly describe a standard latex examination glove, with no mention of any computational or analytical capabilities, let alone AI/ML. The performance study is a biological sensitization test, not a performance evaluation of any software or algorithm.
No
The device, a patient examination glove, is intended to prevent contamination and is not described as directly treating or alleviating a disease or condition in a patient.
No
The device, a "Latex Patient Examination glove," is intended to prevent contamination and does not perform any diagnostic function.
No
The device description clearly states it is a "Latex Patient Examination glove," which is a physical hardware device. There is no mention of software as the primary component or function.
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 function performed in vitro (outside the body).
- Device Description: It's a latex patient examination glove. Gloves are physical barriers, not diagnostic tools.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
- Performance Study: The performance study focuses on sensitization (an allergic reaction), which is related to the material's safety for the user, not its diagnostic capability.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
A glove is worn 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 (.color)
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
healtcare 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
Guinea pig Sensitization (Buehler): Prince of Songkla University, Department of Pharmacology Faculty of Science: Experiment Reference number T95-02 Guinea pig sensitization (Buehler) " There was no evidence of sensitization in both induced (test) guinea pigs and control groups. The results suggest that the risk of contact sensitization in hyman should be minimal"
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
מותר מחוקים של המועד
Image /page/0/Picture/1 description: The image shows the text "Siam Sempermed Corporation.,Ltd" in a simple, sans-serif font. The text is arranged in two lines, with "Siam Sempermed" on the first line and "Corporation.,Ltd" on the second line. The text is black against a white background.
Page 1 of 2
510(k) SUMMARY OCT - 7 1996 01.04.1996
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
PINY color)-80LYY 4.0 Specification: Class I Latex patient examination glove ( meets all of the requirements of ASTM standard D3578-95
5.0 Device Description: Latex Patient Examination glove ( . color)
6.0 Intended use: A glove is worn 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 Inner surface: Pre-powder
- 8.0 Guinea pig Sensitization (Buehler): Prince of Songkla University, Department of Pharmacology Faculty of Science: Experiment Reference number T95-02 Guinea pig sensitization (Buehler) " There was no evidence of sensitization in both induced (test) guinea pigs and control groups. The results suggest that the risk of contact sensitization in hyman should be minimal"
This document and its contents are confidential. Do not discuss with or give access to people not designated.
1
Siam Sempermed · Corporation.,Ltd
Page 2 of 2
510(k) SUMMARY 01.04.1996
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 | SS 77 +/- 5 mm |
| M 95 +/- 10 mm | S 83 +/- 5 mm | |
| L 111 +/- 10 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. |
| POWDER LEVEL | ||
| Inside | N/A | S-2 AQL 4.0 |
| Outside | 2.5+/-1.0% | |
| 1.0% MAX. | ||
| FREEDOM FROM HOLE | S-4 AQL 4.0 | II AQL 1.5 |
PINK
- Conclusion: Siam Sempermed Latex Patient Examination Glove ( color) meet .............................................................................................................................................................................. ASTM standard meet pinhole FDA requirements meet labeling claims (see 5.0 and 6.0 above)
P. Chudkiatgumchai
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.