(255 days)
No
The 510(k) summary describes a standard medical glove and makes no mention of AI or ML technology.
No.
The device is a medical glove intended to prevent contamination, not to treat or diagnose a disease.
No.
The device is a medical glove intended to prevent contamination, not to diagnose a condition.
No
The device description clearly identifies the device as "Powder Free Latex Patient Examination Gloves," which are physical hardware. The entire summary focuses on the physical properties and testing of these gloves.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Intended Use: The intended use of this device is to be worn on the hand to prevent contamination between the examiner and patient bodily fluids, waste, or environment. It's a barrier device.
- Mechanism of Action: The device works by physically preventing contact, not by analyzing a sample taken from the body.
- Device Description: The description focuses on the physical properties of the glove and its testing against chemotherapy drugs, not on any diagnostic capabilities.
The information provided clearly indicates this is a medical glove used for protection and barrier purposes, not for performing diagnostic tests on biological samples.
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
LZC, LYY
Device Description
Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50μg/dm² per glove of extractable protein} meet all the requirements of ASTM standard D6978-05, D5712-054 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
Hand or forefinger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
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 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 D3578-01E4 or equivalent standards.
CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE (Both Predicate and Current)
Dimensions | ASTM D3578-01E1 | Meets
Physical Properties | ASTM D3578-01E1 | Meets
Thickness | ASTM D3578-01E1 | Meets
Powder Free | ASTM D6124-01 | Meets ≤ 2 mg/glove
Protein Level | ASTM D5712-95 | 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
JUL 3 1 2009
Appendix B
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 |
| Fax No.: | +60 3 8706 1485 |
Date of Summary Prepared: July 2008
Name of the device: 2.0
Powder Free 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)
3.0 Identification of The Legally Marketed Devices:
Oncology Plus Powder-Free Latex Examination Gloves (Protein Content Labeling, 50 micrograms or less) Regulatory Class I Product code: LYY 510(k): K972616
4.0 Description of The Device:
Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50μg/dm² per glove of extractable protein} meet all the requirements of ASTM standard D6978-05, D5712-054 and FDA 21 CFR 880.6250.
Intended Use of the Device: 5.0
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 B
510(K) summary Page 2 of 3
510(k) SUMMARY
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free 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 D3578-01E4 or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE
(Both Predicate and
Current) |
|---------------------|---------------------------------------|-------------------------------------------------------|
| Dimensions | ASTM D3578-01E1 | Meets |
| Physical Properties | ASTM D3578-01E1 | Meets |
| Thickness | ASTM D3578-01E1 | Meets |
| Powder Free | ASTM D6124-01 | Meets
≤ 2 mg/glove |
| Protein Level | ASTM D5712-95 | Meets