(162 days)
Not Found
No
The device is a medical glove and the summary does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a glove intended to prevent contamination and protect the wearer, not to treat a disease or condition.
No
The device is a medical glove intended to prevent contamination and protect the wearer, not to diagnose a medical condition.
No
The device is a physical product (gloves) and the description focuses on material properties and performance standards for physical examination gloves. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between examiner and patient and to protect the wearer from chemotherapy drugs. This is a barrier function and protection for the user, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a medical glove meeting standards for examination gloves.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or disease.
- Performance Studies: The performance studies focus on the physical properties and barrier function of the glove, not on diagnostic accuracy metrics like sensitivity, specificity, etc.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use chemotherapy drugs. Tested drugs are as follows:
| Average Breakthrough Detection Time (minutes) | |
|---|---|
| Cisplatin 1.0 mg/ml | ≥ 240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | ≥ 240 |
| Dacarbazine (DTIC) 10.0 mg/ml | ≥ 240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | ≥ 240 |
| Etoposide (Toposar) 20.0 mg/ml | ≥ 240 |
| Fluorouracil 50.0 mg/ml | ≥ 240 |
| Paclitaxel (Taxol) 6.0 mg/ml | ≥ 240 |
Please note that the following drugs have extremely low permeation time for
- Carmustine (BCNU) 3.3mg.ml - 54.1 (mins)
*Thiotepa 10.0 mg/ml - 16.0 (mins)
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) meets all the requirements of ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.
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
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)
Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
- ASTM D412-2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers— ● Tension
- ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an Air Oven .
- ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions ●
- ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical ● Gloves
- . ASTM D6124-2006 (Reapproved 2001) Standard Tested Method for Residual Powder on Medical Gloves
- ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application ●
- ASTM D6978-2005(Reapproved 2019) Standard Practice for Assessment of Resistance of Medical ● Gloves to Permeation by Chemotherapy Drugs
- . ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
- ISO 10993-5 Biological evaluation of medical devices-Part5 Tests for in vitro cytotoxicity ●
- ISO 10993-10 Biological evaluation of medical devices-Part 10 Test for irritation and delayed-type . hypersensitivity
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 27, 2019
Comfort Rubber Gloves Industries Sdn. Bhd. Chan Men QA & QMS Manager Lot 821, Jalan Matang Matang, 34750 My
Re: K190080
Trade/Device Name: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) Regulation Number: 21 CFR 880.6250
Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: March 28, 2019 Received: April 01, 2019
Dear Chan Men:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
Indications for Use (Describe)
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use chemotherapy drugs. Tested drugs are as follows:
| Average Breakthrough Detection Time (minutes) | |
|---|---|
| Cisplatin 1.0 mg/ml | ≥ 240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | ≥ 240 |
| Dacarbazine (DTIC) 10.0 mg/ml | ≥ 240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | ≥ 240 |
| Etoposide (Toposar) 20.0 mg/ml | ≥ 240 |
| Fluorouracil 50.0 mg/ml | ≥ 240 |
| Paclitaxel (Taxol) 6.0 mg/ml | ≥ 240 |
Please note that the following drugs have extremely low permeation time for
- Carmustine (BCNU) 3.3mg.ml - 54.1 (mins)
*Thiotepa 10.0 mg/ml - 16.0 (mins)
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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3
510(k) SUMMARY K190080
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLACK)
1.0 Submitter:
| Name | Comfort Rubber Gloves Industries Sdn. Bhd. |
|---|---|
| Address | Lot 821, Jalan Matang, |
| 34750 Matang, Perak, Malaysia. | |
| Malaysia. | |
| Phone No. | 605-847 2777 |
| Fax No. | 605-847 9108 |
| Contact Person | Chan Yew Men (Mr.) |
Date of Preparation: June 27, 2019
2.0 Name of the Device
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
Common Name: Patient Examination Gloves
Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA) Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC
510(K) Number: K190080
3.0 Predicate Device
Device Name: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) Company: Comfort Rubber Gloves Industries Sdn. Bhd. 510(K)
No.: K180476
4.0 Description of the Device:
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) meets all the requirements of ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.
5.0 Indication for Use of the Device
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) are a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) are summarized with the following technological characteristics compared to ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in Table 1.
4
Chemotherapy claim is similar to Predicate, which has a gloves thickness comply with the ASTM Standards.
Table 1
| CHARACTERISTICS | STANDARDS | PREDICATE DEVICE
K180476 | SUBJECT DEVICE
K190080 | COMPARISON |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer(s) | | Comfort Rubber
Gloves Industries
Sdn. Bhd | Comfort Rubber Gloves
Industries Sdn. Bhd | Same |
| Device Name | | Powder Free Nitrile
Examination Gloves Tested
for Use with Chemotherapy
Drugs Labeling Claim
(Green) | Powder
Free
Nitrile
Examination Gloves Tested
for Use with Chemotherapy
Drugs Labeling Claim
(Black) | Similar |
| Dimension | ASTM 6319-10
(2015) | Length-Min 240mm
Thickness palm and finger-
Min 0.05mm | Length-Min 230mm
Thickness palm and finger-
Min 0.05mm | Similar |
| Physical Properties | ASTM 6319-10
(2015) | Min - 20.23
MPa Min - 445
% | Min - 22.31 MPa
Min - 579% | Similar |
| Thickness - Finger
- Palm | ASTM 6319-10
(2015) | 0.09 mm- 0.10
mm 0.12mm –
0.14 mm | 0.09 mm- 0.10 mm
0.11 mm – 0.13 mm | Similar |
| Powder Content | ASTM 6124-06
(2011)
(≤ 2 mg/glove) | Max - 2 mg/gloves
0.20 mg/glove | Max - 2 mg/gloves
0.60 mg/glove | Same |
| Chemotherapy Drug
Permeation Test | ASTM D6978-
05 | Below | Below | Similar |
| Test Chemotherapy
Drug | Concentration | Minimum Breakthrough Detection Time (min) | | |
| *Carmustine (BCNU) | 3.3 mg/ml | 23.4 | 54.1 | |
| Cisplatin | 1.0 mg/ml | >240 | >240 | |
| Cyclophosphami
de (Cytoxan) | 20 mg/ml | >240 | >240 | |
| Dacarbazine (DTIC) | 10.0 mg/ml | >240 | >240 | |
| Doxorubicin Hydrochloride | 2.0 mg/ml | >240 | >240 | |
| Etoposide (Toposar) | 20.0 mg/ml | >240 | >240 | |
| Fluorouracil | 50.0 mg/ml | >240 | >240 | |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 | >240 | |
| *Thiotepa | 10.0 mg/ml | 16.2 | 16.0 | |
| Warning Statement | | * WARNING :
Please note that the
following drugs have
extremely low permeation
times Carmustine (BCNU):
23.4 minutes and Thiotepa:
16.0 minutes. | * WARNING :
Please note that the
following drugs have
extremely low permeation
times Carmustine (BCNU):
54.1 minutes and Thiotepa:
16.0 minutes. | |
| CHARACTERISTICS | STANDARDS | PREDICATE DEVICE
K180476 | SUBJECT DEVICE
K190080 | COMPARISON |
| Biocompatibility | Primary Skin Irritation ISO
10993-10:2010
Biological evaluation of
medical devices -- Part
10: Tests for irritation and
skin sensitization | Under the conditions of the
study, the subject device
extracts are not irritating to
the animal model. | Under the conditions of the
study, the subject device
extracts are not irritating to
the animal model. | Same |
| | ISO 10993-10:2010
Biological evaluation of
medical devices -- Part
10: Tests for irritation and
skin sensitization | Under the conditions of the
study, the subject device
extracts are not sensitizing
to the animal model. | Under the conditions of the
study, the subject device
extracts are not sensitizing
to the animal model. | Same |
| | Cytotoxicity ISO 10993-
5:2009 - Biological
evaluation of medical
devices -- Part 5: Tests for
in vitro cytotoxicity | Under the conditions of
the study, the subject
device extract exhibits
mild cytotoxicity reactivity
result (score of 2) with the
neat extract (100%). | Under the conditions of
the study, the subject
device extract exhibits
mild cytotoxicity reactivity
result (score of 2) with the
neat extract (100%). | Same |
| Watertight (1000ml) | 21 CFR 800.20
ASTM D5151 | Passes | Passes | Same |
| Indication for Use | | The Powder Free Nitrile
Examination Gloves Tested
for Use with Chemotherapy
Drugs Labeling Claim
(Green) is a specialty
medical glove which is a
disposable device intended
for medical purpose that is
worn on the examiner's hand
or finger to prevent
contamination between
examiner and patient. In
addition, these gloves are
worn to protect the wearer
against exposure to
chemotherapy drugs.
Tested chemotherapy drugs
are as follows:
Average Breakthrough
Detection Time (minutes
Cisplatin, 1.0 mg/ml - ≥ 240
Cyclophosphamide
(Cytoxan), 20.0 mg/ml - ≥
240
Dacarbazine (DTIC), 10.0
mg/ml - ≥ 240
Doxorubicin Hydrochloride,
2.0 mg/ml - ≥ 240
Etoposide (Toposar), 20.0
mg/ml - ≥ 240
Fluorouracil, 50.0 mg/ml - ≥
240
Paclitaxel (Taxol), 6.0 mg/ml - ≥ 240
Please note that the | The Powder Free Nitrile
Examination Gloves Tested
for Use with Chemotherapy
Drugs Labeling Claim
(Black) is a specialty medical
glove which is a disposable
device intended for medical
purpose that is worn on the
examiner's hand or finger to
prevent contamination
between examiner and
patient. In addition, these
gloves are worn to protect
the wearer against exposure
to chemotherapy drugs.
Tested chemotherapy drugs
are as follows: Average
Breakthrough
Detection Time (minutes)
Cisplatin, 1.0 mg/ml - ≥ 240
Cyclophosphamide
(Cytoxan), 20.0 mg/ml - ≥
240
Dacarbazine (DTIC), 10.0
mg/ml - ≥ 240
Doxorubicin Hydrochloride,
2.0 mg/ml - ≥ 240
Etoposide (Toposar), 20.0
mg/ml - ≥ 240
Fluorouracil, 50.0 mg/ml - ≥
240
Paclitaxel (Taxol), 6.0 mg/ml - ≥ 240
Please note that the | Same |
| | | following drugs have
extremely low permeation
time for: Carmustine (BCNU)
3.3mg/ml - 23.4 (mins)
Thiotepa 10.0 mg/ml -
16.2 (mins | following drugs have
extremely low permeation
time for: Carmustine (BCNU)
3.3mg/ml - 54.1 (mins)
Thiotepa 10.0 mg/ml -
16.0 (mins | |
| Material | ASTM D6319 - 10(2015) | Nitrile | Nitrile | Same |
| Color | | Green | Black | Different |
| Size | Medical Glove
Guidance Manual
Labeling | Extra Small
Small
Medium
Large
Extra Large | Extra Small
Small
Medium
Large
Extra Large | Same |
| Single Use | Medical Glove Guidance
Manual -
Labeling | Single Use | Single Use | Same |
5
6
7.0 Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
- ASTM D412-2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers— ● Tension
- ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an Air Oven .
- ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions ●
- ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical ● Gloves
- . ASTM D6124-2006 (Reapproved 2001) Standard Tested Method for Residual Powder on Medical Gloves
- ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application ●
- ASTM D6978-2005(Reapproved 2019) Standard Practice for Assessment of Resistance of Medical ● Gloves to Permeation by Chemotherapy Drugs
- . ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
- ISO 10993-5 Biological evaluation of medical devices-Part5 Tests for in vivo cytotoxicity ●
- ISO 10993-10 Biological evaluation of medical devices-Part 10 Test for irritation and delayed-type . hypersensitivity
8.0 Clinical Performance Data
Clinical data is not needed.
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.