(60 days)
Not Found
No
The device is a standard medical examination glove and the summary contains no mention of AI or ML.
No
Explanation: The device is a patient examination glove used to prevent contamination, not to treat a medical condition.
No
Explanation: The device is described as an examination glove intended to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a physical examination glove, which is a hardware medical device, not software.
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 a patient and an examiner's hand during a medical examination. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description is of a physical glove, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
- Predicate Device: The predicate device is also a latex examination glove, which is not an IVD.
IVDs are devices used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that definition.
N/A
Intended Use / Indications for Use
This device is a disposable device intended for medical purpose that is worn on the examiner 's hand to prevent contamination between patient and examiner.
A patient examination glove is a disposable intended for medical purposes A patient examiner's hand or finger to prevent contamination between patient and examiner
Product codes
LYY
Device Description
Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less)
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
Not Found
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
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
Key Metrics
Not Found
Predicate Device(s)
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
510 (k) Summary As Required by 21 section 807.92 ( c)
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- Submitter Name: Siam Sempermed Corp., Ltd
JUL 1 9 2005
- 110 Kanjanavanit Road. Pathong Hatyai 2. Address: Songkhla. Thailand 90230
- (+66) 74 291 648 3. Phone:
- (+66) 74 291 650 Fax: 4.
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- Contract Person: Mrs. Sureerat Choosri (Product Manager)
- Date summary prepared: Mar 31, 2005 6.
- Official Correspondent: Sempermed USA Inc. 7.
- 13900 49th Street North 8. Address: Clearwater, USA , FL 33762
- 727 787 7250 9. Phone:
- 727 787 7558 10. Fax:
- Mr. William E. Harris 11. Contact person:
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- Device Trade or Proprietary Name: Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less).
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- Device Common or usual name: Examination glove
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- Device Classification Name: Glove , Patient Examination , Latex
15. Description of the Device:
ISterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less)
16. Intended use of the device:
This device is a disposable device intended for medical purpose that is worn on the examiner 's hand to prevent contamination between patient and examiner.
17. Summary of The Technological Characteristics of The devices :
Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578-2001-ae2 | Meets |
| Physical Properties | ASTM D 3578-2001-ae2 | Meets |
| Freedom from pinholes | ASTM D 3578-2001-ae2 | Meets |
| Powder Free Residue | ASTM D 6124-2001 | $≤$ 2 mg/glove |
| Protein Level | ASTM D 5712-99 | $ |