(149 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a disposable examination glove, with no mention of AI or ML.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner." Its function is protective, not diagnostic.
No
The device is a physical product (gloves) and the summary describes physical and biocompatibility testing, not software characteristics or performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "powder-free patient examination glove... to prevent contamination between patient and examiner." This is a barrier device used for protection, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description focuses on the material (Nitrile), form (powder-free, non-sterile), and color. It doesn't mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies listed are related to the physical properties and biocompatibility of the glove (dimensions, strength, freedom from holes, skin irritation, sensitization). These are relevant to a barrier device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic output.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
A powder-free 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
LZA
Device Description
The proposed device is a disposable device intended for over the counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. Gloves are not made with natural rubber latex. The glove color is cool blue.
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's hand; 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
Biocompatibility: Primary Skin Irritation. ISO 10993-10. Gloves are non-irritating.
Guinea Pig Maximization. ISO 10993-10. Gloves do not display any potential for sensitization.
Physical Characteristics: Dimensions. ASTM D6319. Meet requirements.
Physical Properties. ASTM D6319. Meet requirements.
Freedom from Holes (Water Leak test). 21 CFR 800.20 & ASTM D6319. Tested in accordance with ASTM D5151 test method with acceptable results.
Powder Residual. ASTM D6319. Tested using ASTM D6124 test method. Gloves meet powder level requirements for "Powder-Free" designation per ASTM D6319. Results generated values
§ 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
K122696
JAN 3 1 2013
510(K) SUMMARY
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
(A510(k) summary information in accordance with the requirements of 21 CFR 807.92)
| Applicant: | Cardinal Health |
|---|---|
| 1430 Waukegan Road | |
| McGaw Park, IL 60085 |
Establishment Registration
| Number: | 1423537 |
|---|---|
| --------- | --------- |
Regulatory Affairs
| Contact: | Tatyana Bogdan, RAC |
|---|---|
| Telephone: | 847-887-2325 |
| Fax: | 847-887-2717 |
| E-mail: | tatyana.bogdan-curvin@cardinalhealth.com |
Summary Prepared: October 21, 2012
Trade Name: Powder-Free Nitrile Exam Gloves (Cool Blue) Common Name: Exam Gloves Classification Name: Patient Examination Gloves Classification Panel: General Hospital Regulation: 21 CFR 880.6250 Product Code(s): LZA Legally marketed device(s) to which equivalenceNitrile Comflower Blue Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs previously cleared under 510(k) K103249 (product code LZA); Reason for 510(k) Submission : New device Device Description: The proposed device is a disposable device intended for over the counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. Gloves are not made with natural rubber latex. The glove color is cool blue. Intended Use: A powder-free 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.
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1
| Summary of the technological characteristics of the device compared to the predicate device | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Characteristic | New Device | Predicate Device | ||||||||||||||||||||||
| Material | ||||||||||||||||||||||||
| Composition | Nitrile | Nitrile Cornflower Blue Powder-Free Examination | ||||||||||||||||||||||
| Gloves Tested for Use with Chemotherapy drugs | ||||||||||||||||||||||||
| (K103249) | ||||||||||||||||||||||||
| Design | Powder-Free | |||||||||||||||||||||||
| Ambidextrous | ||||||||||||||||||||||||
| Beaded Cuff | ||||||||||||||||||||||||
| Non-Sterile | Powder-Free | |||||||||||||||||||||||
| Ambidextrous | ||||||||||||||||||||||||
| Beaded Cuff | ||||||||||||||||||||||||
| Non-Sterile | ||||||||||||||||||||||||
| Color | Cool Blue | Cornflower Blue | ||||||||||||||||||||||
| Intended Use / | ||||||||||||||||||||||||
| Indications for Use | A powder-free | |||||||||||||||||||||||
| 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 powder-free 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. |
In addition, these gloves were tested for use with
chemotherapy drugs in accordance with ASTM
D6978-05 Standard Practice for Assessment of
Medical Gloves to Permeation by Chemotherapy
Drugs: | | | | | | | | | | | | | | | | | | | | | | |
| | | Chemotherapy Drug and
Concentration Minimum
Breakthrough
Detection Time
in Minutes, 0.01
µg/cm²/minute Carmustine (BCNU) (3.3
mg/ml) 7.28 Cisplastin, (1.0mg/ml) >240 Cyclophosphamide (20
mg/ml) >240 Doxorubicin HCl (2.0 mg/ml) >240 Etoposide (Toposar) (20
mg/ml) >240 5-Fluorouracil (50 mg/ml) >240 Methotrexate (25 mg/ml) >240 Paclitaxel (Taxol) (6.0 mg/ml) >240 Thiotepa (10 mg/ml) 2.67 The maximum testing time is 240 minutes. Please
note that the following drugs have extremely low
permeation time of less than 30 minutes: Carmustine
(BCNU) (3.3 mg/ml), Thiotepa (10 mg/ml) | | | | | | | | | | | | | | | | | | | | | | |
| Dimensions &
Physical Properties | Meets ASTM D6319 | Meets ASTM D6319 | | | | | | | | | | | | | | | | | | | | | | |
.
Cardinal Health, Inc. :: . Premarket Notification Submission – Traditional 510(k)
2
.
2
| Freedom from
Holes | AQL meets 21CFR
800.20 & ASTM
D6319 requirements | AQL meets 21CFR 800.20 & ASTM D6319
requirements | |
|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Powder Residual | Meets requirements
of ≤2.0 mg/glove for
Powder-Free
designation per
ASTM D6319 | Meets requirements of ≤2.0 mg/glove for Powder-
Free designation per ASTM D6319 | |
| PERFORMANCE DATA | | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF
SUBSTANTIAL EQUIVALENCE* | | | |
| Performance Test Summary-New Device | | | |
| Characteristic | Standard/Test/FDA
Guidance | Results Summary | |
| Biocompatibility:
Primary Skin Irritation | ISO 10993-10 | Gloves are non-irritating. | |
| Guinea Pig
Maximization | ISO 10993-10 | Gloves do not display any potential for
sensitization. | |
| Physical
Characteristics:
Dimensions | ASTM D6319 | Meet requirements | |
| Physical Properties | ASTM D6319 | Meet requirements | |
| Freedom from Holes
(Water Leak test) | 21 CFR 800.20 &
ASTM D6319 | Tested in accordance with ASTM D5151 test
method with acceptable results | |
| Powder Residual | ASTM D6319 | Tested using ASTM D6124 test method.
Gloves meet powder level requirements for
"Powder-Free" designation per ASTM
D6319. Results generated values