(145 days)
Not Found
No
The device is a physical examination glove and the summary describes standard material properties and testing for chemical resistance, 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 treat a medical condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner and for use with chemotherapy drugs. It does not perform any diagnostic function.
No
The device description clearly states it is a physical glove 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 examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device for physical protection, not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a medical condition.
- Device Description: The description reinforces that it's a glove for physical protection. The testing for chemotherapy drug permeation is a performance characteristic related to its barrier function, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic devices.
- Performance Studies: The performance studies focus on physical properties (tensile strength, elongation, freedom from holes) and barrier function (chemotherapy drug permeation), which are relevant to a protective glove, not an IVD.
In summary, the device is a medical glove intended for physical protection and contamination prevention, not for performing diagnostic tests on samples outside the body.
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.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free and are made of nitrile with a blue colorant. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The subject device was tested according to ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy agents.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers of examiners
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical purposes between patient and 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)
Non-Clinical Testing:
Biocompatibility evaluation in accordance with ANSVAAMI/ISO 10993-1:2009. The device is classified as a surface contacting device with a limited contact duration of less than 24 hours. Tests performed: ISO 10993-10: Primary Skin Irritation Test and ISO 10993-10: Closed Patch Sensitization Test.
Key results: Not an irritant, not a skin sensitizer.
Performance Testing (Bench):
Physical performance qualities evaluated per ASTM D6319, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing conducted according to ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times determined for a wide range of chemotherapy drugs.
Key results:
Carmustine 3.3mg/ml - 40.4 min.
Cisplatin 1.0mg/ml - No breakthrough up to 240 min.
Cyclophosphamide 20.0mg/ml - No breakthrough up to 240 min.
Dacarbazine 2.0mg/ml - No breakthrough up to 240 min.
Doxorubicin Hydrochloride 2/0mg.ml - No breakthrough up to 240 min.
Etoposide 20.0mg/ml - No breakthrough up to 240 min.
Fluoruouracil 50mg/ml - No breakthrough up to 240 min.
Methotrexate 25mg - No breakthrough up to 240 min.
Mitoxantrone 2.0mg/ml - No breakthrough up to 240 min.
Paclitaxel 5.0mg/ml - No breakthrough up to 240 min.
Thiotepa 10mg/ml - 60.6 min.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 19, 2016
Medline, Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundelein, Illinois 60060
Re: K161473
Trade/Device Name: Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: September 14, 2016 Received: September 16, 2016
Dear Jennifer Mason:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161473
Device Name
Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
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.
The following chemicals have been tested with these gloves.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
Carmustine 3.3mg/ml - 40.4 min. Cisplatin 1.0mg/ml - No breakthrough up to 240 min. Cyclophosphamide 20.0mg.ml - No breakthrough up to 240 min. Dacarbazine 2.0mg/ml - No breakthrough up to 240 min. Doxorubicin Hydrochloride 2/0mg.ml - No breakthrough up to 240 min. Etoposide 20.0mg/ml - No breakthrough up to 240 min. Fluoruouracil 50mg/ml - No breakthrough up to 240 min. Methotrexate 25mg - No breakthrough up to 240 min. Mitoxantrone 2.0mg/ml - No breakthrough up to 240 min. Paclitaxel 5.0mg/ml - No breakthrough up to 240 min. Thiotepa 10mg/ml - 60.6 min.
Please note that the following drugs have extremely low permeation times: Carmustine (3.3 mg/ml) has a minimum breakthrough time of 40.4 minutes; Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 60.6 minutes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image features the Medline logo, set against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized star or cross symbol. The symbol is white, contrasting with the blue background, and appears to be composed of four elongated triangles converging at a central point. A small gray rectangle is visible in the upper right corner of the image.
Aedline Industries, Inc. One Medline Place Mundelein, IL 60060
K161473 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060
Registration Number: 1417592
Contact Person
Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: JAMason@medline.com
Summary Preparation Date September 14, 2016
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) Proprietary Name: Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) Common Name: Patient Examination Glove Classification Name: Patient Examination Glove Product Code: LZA, LZC Classification Panel: General Hospital Regulatory Class: I Regulation #: 21 CFR 880.6250
Predicate Device
EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs K141623
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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is in white, bold, sans-serif font, and to the right of the word is a white starburst symbol. There is a gray bar on the right side of the image.
ledline Industries, Inc. One Medline Place Mundelein, IL 60060
Device Description
The Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free and are made of nitrile with a blue colorant. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The subject device was tested according to ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy agents.
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 Glove to Permeation by Chemotherapy Drugs.
| Chemotherapy Drugs | Breakthrough Times |
|---|---|
| Carmustine 3.3mg/ml | 40.4 min. |
| Cisplatin 1.0mg/ml | No breakthrough up to 240 min. |
| Cyclophosphamide 20.0mg/ml | No breakthrough up to 240 min. |
| Dacarbazine 2.0mg/ml | No breakthrough up to 240 min. |
| Doxorubicin Hydrochloride 2.0mg/ml | No breakthrough up to 240 min. |
| Etoposide 20.0mg/ml | No breakthrough up to 240 min. |
| Fluorouracil 50mg/ml | No breakthrough up to 240 min. |
| Methotrexate 25mg/ml | No breakthrough up to 240 min. |
| Mitoxantrone, 2.0mg/ml | No breakthrough up to 240 min. |
| Paclitaxel 5.0mg/ml | No breakthrough up to 240 min. |
| Thiotepa 10mg/ml | 60.6 min. |
The following chemicals have been tested with these gloves
Please note that the following drugs have extremely low permeation times: Carmustine (3.3 mg/ml) has a minimum breakthrough time of 40.4 minutes; Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 60.6 minutes.
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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized white starburst symbol to the right of the text. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060
Summary of Technological Characteristics
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
| Device Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline Powder-Free Blue
Nitrile Exam Glove Extended
Cuff (Tested for Use with
Chemotherapy Drugs) | EMG Blue Nitrile
Examination Gloves Powder
Free with tested for use with
chemotherapy drugs | Different |
| 510(k) Reference | K161473 | K141623 | N/A |
| Product Owner | Medline Industries, Inc. | Eco Medi Glove SDN BHD | Different |
| Product Code | LZA, LZC | LZA, LZC | Same |
| 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 and for use with
chemotherapy drugs. In
addition these gloves were
tested for use with
chemotherapy drugs in
accordance with ASTM
D6978-05 Standard Practice
for Assessment of Medical
Glove to Permeation by
Chemotherapy Drugs. | 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 and for use with
chemotherapy drugs. In
additional these gloves were
tested for use with
chemotherapy drugs in
accordance with ASTM
D6978-05 standards Practice
for assessment of Medical
Glove to Permeation by
Chemotherapy drugs. | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Materials | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Design Configurations | Small
Medium
Large
Extra-Large | Small
Medium
Large
Extra-Large | Same |
| Dimensions - Length | Complies with ASTM D6319-
10
270mm min. | Complies with ASTM D6319-
10
270mm min. | Same |
| Dimensions - Width | Complies with ASTM D6319-
10
Small - 80 ±10mm min.
Medium - 95 ±10mm min. | Complies with ASTM D6319-
10
Small - 85 ±5mm min.
Medium - 95 ±5mm min. | Same |
| | | | |
| | Large - 110±10mm min. | Large - 105±5mm min. | |
| | Extra-Large 120±10mm min. | Extra-Large 115±5mm min. | |
| Dimensions - Thickness | Complies with ASTM D6319-
10 | Complies with ASTM D6319-
10 | Same |
| | Palm - 0.10mm min. | Palm - 0.10mm min. | |
| | Finger - 0.10mm min. | Finger - 0.10mm min. | |
| Physical Properties -
Tensile | Complies with ASTM D6319-
10 | Complies with ASTM D6319-
10 | Same |
| | Before Aging - 14 MPa, min. | Before Aging - 14 MPa, min. | |
| | After Aging - 14 MPa, min. | After Aging - 14 MPa, min. | |
| Physical Properties -
Elongation | Complies with ASTM D6319-
10 | Complies with ASTM D6319-
10 | Same |
| | Before Aging – 500% min. | Before Aging – 500% | |
| | After Aging - 400% min. | After Aging - 400% | |
| Freedom from Holes | AQL 1.5 Inspection level G-2
Meets ASTM D6319-10 | AQL 2.5 Inspection level G-1
Meets ASTM D6319-00a | Similar |
| Residual Powder | Complies with ASTM D6319-
10