(127 days)
Not Found
No
The device description and intended use clearly define a standard patient examination glove, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is a patient examination glove, which is a barrier device for contamination prevention, not a therapeutic device designed to treat or alleviate a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not collect or analyze data to provide a medical diagnosis.
No
The device description clearly states it is a physical glove made from synthetic rubber latex, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for preventing contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description focuses on the material (nitrile), manufacturing process, and physical properties of the glove. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device described is a Class I medical device (specifically, a patient examination glove) intended for infection control and barrier protection.
N/A
Intended Use / Indications for Use
A 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Powder Free Black Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Powder Free Black Nitrile Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards.
Sterility status: ISO11137-1:2006, Non-Sterile.
Dimensions: ASTM D6319-10, Meets.
Physical Properties: ASTM D6319-10, Meets.
Thickness: ASTM D6319-10, Meets.
Powder Free: ASTM D6124-06, 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
DEC 13 2013
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: 25 July 2013
2.0 Name of the device:
Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile Common Name: Exam Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA)
3.0 Identification of The Legally Marketed Devices that equivalency is claimed:
Dermagrip-N Powder Free Blue Nitrile Examination Gloves 510(k) : K022904 MDL : D036500 Regulatory Class I Product Code : LZA
4.0 Description of The Device:
Powder Free Black Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
5.0 Intended Use of the Device:
A 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.
1
510(k) SUMMARY
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Black Nitrile Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---|---|---|---|
| Predicate | Current | ||
| Name | - | Dermagrip-N | |
| Powder Free | |||
| Blue Nitrile | |||
| Examination | |||
| Gloves | Dermagrip | ||
| Powder Free | |||
| Black Nitrile | |||
| Patient | |||
| Examination | |||
| Gloves, Non- | |||
| Sterile | |||
| Sterility status | ISO11137-1:2006 | Non-Sterile | Non-Sterile |
| Dimensions | ASTM D6319-10 | Meets | Meets |
| Physical Properties | ASTM D6319-10 | Meets | Meets |
| Thickness | ASTM D6319-10 | Meets | Meets |
| Powder Free | ASTM D6124-06 | Meets |