(43 days)
Not Found
No
The 510(k) summary describes a standard patient examination glove and its performance characteristics, with no mention of AI or ML technology.
No.
A therapeutic device is used to treat or cure a disease or condition. These gloves are intended to prevent contamination between the patient and examiner and protect against chemotherapy drugs, not to provide therapy.
No
This device is a patient examination glove used to prevent contamination, which is a protective barrier, not a diagnostic tool.
No
The device description clearly states it is a physical product (patient examination gloves) made of Nitrile, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "powder-free patient examination glove" worn on the hand or finger to prevent contamination between patient and examiner. This is a barrier device for physical protection.
- Device Description: The description reinforces that it's a disposable glove made of Nitrile.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies focus on the physical properties of the glove (irritation, sensitization, dimensions, strength, freedom from holes, powder residual, and chemotherapy permeation resistance). These are all related to the glove's function as a barrier and protective device, not a diagnostic tool.
IVD devices are specifically designed to perform tests on biological samples to gain diagnostic information. 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.
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 | |
|---|---|---|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 7.28 |
| 2. | Cisplastin, (1.0mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCI (2.0 mg/ml) | >240 |
| 5. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 6. | 5-Fluorouracil (50 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 9. | 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)
Product codes
LZA
Device Description
These patient examination gloves are formulated using Nitrile. They are a disposable device that is offered powder-free and nonsterile. Gloves are comflower blue in color. Gloves are not made with natural rubber latex.
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
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)
Performance Testing:
| Test: | Result: |
|---|---|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |
| Dimensions | Gloves meet requirements of ASTM D6319. |
| Physical Characteristics ASTM | Gloves meet requirements for Nitrile examination gloves per D6319. |
| Freedom from Holes | Gloves meet requirements of 21 CFR 800.20 and ASTM D6319 |
| Powder Residual | Gloves meet powder level requirements for “Powder-Free” designation per ASTM D6319 tested using ASTM standard D6124, Standard test method for residual powder on medical gloves. Results generated values below 2mg of residual powder per glove. |
| Chemotherapy Permeation | Gloves were tested using ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The maximum testing time is 240 minutes. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic of three curved lines above the company name. The text "CardinalHealth" is written in a bold, sans-serif font.
DEC 16 2010
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
NITRILE POWDER-FREE EXAMINATION GLOVES
YTY Industry (Manjung) Sdn. Bhd. Manufacturer: Lot 1422 - 1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia
Regulatory Affairs Contact: Tatyana Bogdan, RAC Cardinal Health, Inc. 1430 Waukegan Road McGaw Park, IL 60085
847-887-2325 Telephone:
-
October 11, 2010 Date Summary Prepared:
Stretchy Nitrile Cornflower Blue Powder-Free Exam Gloves with Product Trade Name: Tested for Use with Chemotherapy Drug Labeling Claim -
Exam Gloves Common Name:
-
Classification Name: Patient Examination Gloves
-
Device Description: These patient examination gloves are formulated using Nitrile. They are a disposable device that is offered powder-free and nonsterile. Gloves are comflower blue in color. Gloves are not made with natural rubber latex.
1
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.
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 |
|----|----------------------------------------|-----------------------------------------------------------------------|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 7.28 |
| 2. | Cisplastin, (1.0mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCI (2.0 mg/ml) | >240 |
| 5. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 6. | 5-Fluorouracil (50 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 9. | 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)
Predicate Devices:
Nitrile Blue Powder-Free Examination Gloves with Tested for Use with Chemotherapy Drug Labeling Claim previously cleared under 510(k) K022765 (product code LZA);
Substantial Equivalence:
These Nitrile powder-free examination gloves are substantially equivalent to the predicate device identified in this 510(k) summary. Substantial equivalence can be established in regard to intended use, physical characteristics, design and product features. Both gloves are made with Nitrile using similar manufacturing processes. In addition, both gloves have been tested for use with chemotherapy drugs.
Performance Testing:
| Test: | Result: |
|---|---|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |
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| Dimensions | Gloves meet requirements of ASTM D6319. |
|---|---|
| Physical Characteristics | |
| ASTM | Gloves meet requirements for Nitrile examination gloves per |
| D6319. | |
| Freedom from Holes | Gloves meet requirements of 21 CFR 800.20 and ASTM D6319 |
| Powder Residual | Gloves meet powder level requirements for “Powder-Free” |
| designation per ASTM D6319 tested using ASTM standard | |
| D6124, Standard test method for residual powder on medical | |
| gloves. Results generated values below 2mg of residual powder | |
| per glove. | |
| Chemotherapy Permeation | Gloves were tested using ASTM D6978, Standard Practice for |
| Assessment of Resistance of Medical Gloves to Permeation by | |
| Chemotherapy Drugs. The maximum testing time is 240 minutes. | |
| Clinical Data: |
No clinical data is required.
Conclusion:
The Stretchy Nitrile Powder-Free Exam Gloves meet the technological characteristics of ASTM D6319 performance standard and are substantially equivalent to the predicate device identified in this 510(k) summary.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
l
Cardinal Health, Incorporated C/O Ms. Tatyana Bogdan Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
DEC 16 2010
Re: K103249
Trade/Device Name: Nitrile Comflower Blue Powder-Free Exam Gloves tested for use with Chemotherapy Drugs Labeling Claim . Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 10, 2010 Received: December 13, 2010
Dear Ms. Bogdan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Ms. Bogdan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jams Jizdado
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
2
Radiological Health
Enclosure ·
5
050 16 2013
Indications for Use
510(k) Number (if known): K1032 49
Nitrile Comflower Blue Powder-Free Exam Gloves WiTH TESTED for Device Name: USE with Chemotherary Drugs Labeling Claim
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.
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 |
|----|----------------------------------------|-----------------------------------------------------------------------|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 7.28 |
| 2. | Cisplastin, (1.0mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 5. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 6. | 5-Fluorouracil (50 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 9. | 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)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Elight D-Clawro Well
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| Page __ of __ | |
|---|---|
| 510(k) Number: | K103249 |
Cardinal Health, Inc.
Premarket Notification Submission - Traditional 510(k)
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