(253 days)
Not Found
No
The device is a chemotherapy examination glove, and the description focuses on its physical properties and resistance to chemotherapy drugs, with no mention of AI or ML.
No
The device is described as a medical glove intended to prevent contamination between examiner and patient, and specifically tested for chemotherapy drug resistance, not for treating a disease or condition.
No
The device is described as a "disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination." This description indicates it is a barrier device for protection, not a device used to diagnose a medical condition.
No
The device is a physical medical glove, not software. The description details its material, testing against standards, and intended use as a barrier.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for preventing contamination between the examiner and patient bodily fluids, waste, or environment. It's a barrier device.
- Device Description: The description focuses on the physical properties and standards met for a medical glove.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases. IVDs are designed to perform tests in vitro (outside the body).
- Performance Studies: The performance studies focus on the physical properties of the glove (dimensions, strength, watertightness, chemotherapy resistance) and biocompatibility, not on diagnostic accuracy or analytical performance related to a biological sample.
This device is a medical device, specifically a medical glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Cyclophosphamide, Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel]
WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE
Product codes (comma separated list FDA assigned to the subject device)
LZC
Device Description
Powder Free Blue Latex Examination Gloves 18 Mil, with Chemotherapy Drugs & Protein Content Labeling Claim meets all the requirements of ASTM standard D6978-05, D5712-05°1 and FDA 21 CFR 880.6250.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands / forefinger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical professional)
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)
The Powder Free Blue Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50µg/dm² per glove of extractable protein) are summarized with the following technological characteristics compared to ASTM D3578-05 or equivalent standards.
CHARACTERISTICS - Dimensions; STANDARDS - ASTM D3578-05; DEVICE PERFORMANCE - Meets
CHARACTERISTICS - Physical Properties; STANDARDS - ASTM D3578-05; DEVICE PERFORMANCE - Meets
CHARACTERISTICS - Thickness; STANDARDS - ASTM D3578-05; DEVICE PERFORMANCE - Meets
CHARACTERISTICS - Powder Free; STANDARDS - ASTM D6124-06; DEVICE PERFORMANCE - Meets
§ 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
Appendix C
510(K) summary Page 1 of 3
510(k) SUMMARY
1.0 Submitter:
Name: Mr. Kirk Penner Address: WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA Phone No.: +60 3 8706 1486 +60 3 8706 1485 Fax No.:
Date of Summary Prepared: July 2008
2.0 Name of the device:
Powder Free Blue Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50µg/dm² per glove of extractable protein)
Common Name: Exam Gloves Classification Name: Patient Examination Gloves, Specialty Chemotherapy (21 CFR 880.6250 product code LZC)
510(k) K083409
3.0 Identification of The Legally Marketed Devices:
Chemoplus Powder Free Blue latex Examination Gloves with Protein Labeling Claim 50 Micrograms or less. Regulatory Class I Product code: LYY 510(k): K972615
4.0 Description of The Device:
Powder Free Blue Latex Examination Gloves 18 Mil, with Chemotherapy Drugs & Protein Content Labeling Claim meets all the requirements of ASTM standard D6978-05, D5712-05°1 and FDA 21 CFR 880.6250.
5.0 Intended Use of the Device:
The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Cyclophosphamide, Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel]
WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE
1
Appendix C
510(K) summary Page 2 of 3
510(k) SUMMARY
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Blue Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50µg/dm² per glove of extractable protein) are summarized with the following technological characteristics compared to ASTM D3578-05 or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE
(Both Predicate and
Current) |
|---------------------|---------------------------------------|-------------------------------------------------------|
| Dimensions | ASTM D3578-05 | Meets |
| Physical Properties | ASTM D3578-05 | Meets |
| Thickness | ASTM D3578-05 | Meets |
| Powder Free | ASTM D6124-06 | Meets