(63 days)
Not Found
Not Found
No
The device is a patient examination glove, and the summary describes its material and intended use for preventing contamination. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
No.
The intended use states it is to "prevent contamination between patient and examiner," which is a preventive measure, not a therapeutic one. It does not treat or cure any medical condition.
No
Explanation: The device is a patient examination glove, described as preventing contamination between the patient and examiner. Its intended use does not involve diagnosing medical conditions, but rather providing a barrier. The performance study focuses on skin irritation and sensitization, not diagnostic accuracy.
No
The device is a physical glove, not software. The description clearly states "Latex Patient Examination glove Powderfree".
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 "disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The device is described as a "Latex Patient Examination glove Powderfree." This is a physical barrier, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening
The information provided focuses on the physical properties and safety of the glove as a barrier, which is consistent with a Class I or Class II medical device used for protection, not an IVD.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner,
Product codes
80LYY
Device Description
Latex Patient Examination glove Powderfree
50 micrograms or less of total water extractable protein per gram of glove
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
Human Repeat Insult Patch Test: Concordia Research Laboratories, Inc.
Study Number: Not Found
"Because of the complete lack of reactions during both the Induction and Challenge Phases, it is apparent that this test glove, when tested under the exaggerated conditions of the Occluded Repeated Insult Patch Test, may be safely distributed for its intended use.It is the opinion of the investigator and dermatologist that the Irritation and sensitization potential of the above captioned test article is extremely low, if existent at all."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
| Sempermed Corporation., Ltd | Page 1 of 2 | |
|---|---|---|
| MAY -6 1997 | 510(k) SUMMARY -08.01.1997 FOR K-970794 | |
| 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 | MR DON MORRIS | |
| SIAM SEMPERMED CORPORATION.Ltd | SATARI CORP. Ltd | |
| 110 MOO 8 KANJANAVANIT ROAD | 14 LEEWARD ISLAND | |
| PATHONG HATYAI SONGKHLA | CLEARWATER | |
| THAILAND 90230 | USA FL 34630 | |
| TEL: 66 074 291 648 OR 291 649 | TEL: 813 446 3535 OR 800 366 9545 | |
| FAX: 66 074 291 650 | FAX: 813 443 348 | |
| 3.0 Device Class: I | ||
| Product code: 80LYY | ||
| 4.0 Specification: Latex patient examination glove (powderfree)-Class 1 80LYY | ||
| meets all of the requirements of ASTM standard D3578-95 | ||
| 5.0 Device Description: Latex Patient Examination glove Powderfree | ||
| 50 micrograms or less of total water extractable protein per gram of glove | ||
| 6.0 Intended use: A patient examination glove is a disposable device intended for medical purposes that is worn | on the examiners hand or finger to prevent contamination between patient and examiner, | |
| 7.0 Surface treatment: Polymer coated, Halogenation/Siliconization and extensive washing in water | ||
| Outer surface: Free from glove powder | ||
| 8.0 Human Repeat Insult Patch Test: Concordia Research Laboratories, Inc. | Study Number: | |
| "Because of the complete lack of reactions during both the Induction and Challenge Phases, it is apparent that | ||
| this test glove, when tested under the exaggerated conditions of the Occluded Repeated Insult Patch Test, | ||
| may be safely distributed for its intended use. | ||
| It is the opinion of the investigator and dermatologist that the Irritation and sensitization potential of the above | ||
| captioned test article is extremely low, if existent at all." |
1
Sempermed D Corporation., Ltd
510(k)- SUMMARY
08.01:1997 · · POR K-970794
· 9.0 QUALITY CHARACTERISTICS
| DESCRIPTION | ASTM standard | SPECIFICATION |
|---|---|---|
| DIMENSION | S-2 AQL 1.0 | 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 ≤80 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 | ||
| Before and aging | S-Z AQL 4.0 | S-2 AQL 4.0 |
| Tensile strength | ||
| Elongation at break | According to | |
| ASTM D3578-95 | 14 Mpa MIN | |
| 700% MIN. | ||
| after aging | ||
| tensile strength | ||
| Elongation at break | 14 Mpa MIN. | |
| 500% MIN. | ||
| WATER EXTRACTABLE | ||
| PROTEIN | N/A | S-2 AQL 4.0 |
| 50 ug/g MAX. | ||
| POWDER LEVEL | N/A | 2 mg MAX. |
| FREEDOM FROM HOLE | S-4 AQL 4.0 | II AQL 1.5 |
- Coaclesian: Siam Sempermed Latex Patient Examination Glove polymer Powdsfree moct the ASTM standard or equivalent standard moot pinhole FDA requirements
ment labeling claims (see 5.0 and 6.0 above)
Dr. POONSUK CHERDKIATGUMCHAI
Senior Assistant Chief Production Officer (quality)
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