(186 days)
(No Predicate Device information was found in the provided text.)
Not Found
No
The summary describes a standard latex examination glove and does not mention any AI or ML components or functionalities.
No.
The device's intended use is to prevent contamination, which is a protective rather than a therapeutic function.
No
Explanation: The device is described as a glove for preventing contamination between healthcare personnel and patients, fluids, or the environment. Its primary function is protective, not diagnostic.
No
The device description clearly states it is a "Latex Patient Examination glove," which is a physical hardware device.
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: It's a latex patient examination glove. This is a physical barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting substances, or providing diagnostic information.
IVD devices are used to examine specimens 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 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 (color)
Mentions image processing
Not Found
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
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
Not Found
Summary of Performance Studies
Guinea pig Sensitization (Buehler): Prince of Songkla University, Department of Phamacology 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
Siam Sempermed Corporation.,Ltd
OCT -7 1996
Page 1 of 2
510(k) SUMMARY 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
- ្របប / អរៈប្រទ 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: 1 Product code: 80LYY
BITE
4.0 Specification: Class I Latex patient examination glove ( color)-80LYY meets all of the requirements of ASTM standard D3578-95
BIVE
5.0 Device Description: Latex Patient Examination glove ( color)
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 Inner surface: Pre-powder
- 8.0 Guinea pig Sensitization (Buehler): Prince of Songkla University, Department of Phamacology 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"
1
K9611415
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 | |
| 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 | ||
| palm | 0.08 mm MIN. | |
| 0.08 mm MIN. | 0.08 mm MIN. | |
| 0.08 mm MIN. | ||
| PHYSICAL PROPERTIES | S -2 AQL 4.0 | S-2 AQL 4.0 |
| Before aging | ||
| Tensile strength | ||
| Elongation at break | 14 Mpa MIN. | |
| 700 % MIN. | 14 Mpa MIN | |
| 700% MIN. | ||
| After aging | ||
| Tensile strength | ||
| Elongation at break | 14 Mpa MIN. | |
| 500% MIN. | 14 Mpa MIN. | |
| 500% MIN. | ||
| POWDER LEVEL | ||
| Inside | ||
| Outside | N/A | S-2 AQL 4.0 |
| 2.5⁺⁄⁋1.0% | ||
| 1.0% MAX. | ||
| FREEDOM FROM HOLE | S-4 AQL 4.0 | II AQL 1.5 |
BIVE
- Conclusion: Siam Sempermed Latex Patient Examination Glove ( color) ASTM standard · meet ・・ meet pinhole FDA requirements meet labeling claims (see 5.0 and 6.0 above)
P. Cherdkiatgumchai
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.