(203 days)
Not Found
No
The device is a physical glove and the summary describes only physical and chemical testing, with no mention of software, algorithms, or data processing.
No
Explanation: A therapeutic device is used to treat or manage a disease or condition. This device, an examination glove, is intended to prevent contamination, not to treat a medical condition.
No.
The device is a non-sterile, powder-free nitrile examination glove, intended to prevent contamination between patient and examiner, which is a protective function rather than a diagnostic one.
No
The device description clearly states it is a "Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs," which is a physical, disposable hardware device. The performance studies also focus on physical properties and standards related to gloves.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection during medical examinations.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The device is described as a "Non-sterile, Powder-Free Nitrile Examination Glove." This is consistent with a barrier device, not a diagnostic test.
- Performance Studies: The performance studies listed focus on the physical properties and safety of the glove (tension, deterioration, dimensions, holes, powder, biocompatibility), not on the ability to diagnose or detect substances in a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The testing with chemotherapy drugs and fentanyl is to demonstrate the glove's ability to act as a barrier against these substances, which is a performance characteristic of a protective device, not a diagnostic one.
N/A
Intended Use / Indications for Use
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs are as follows:
- Carmustine (BCNU) 3.3 mg/mL Cisplatin 1.0 mg/mL Cyclophosphamide (Cytoxan) 20 mg/mL Dacarbazine (DTIC) 10.0 mg/mL Doxorubicin Hydrochloride 2.0 mg/mL Etoposide (Toposar) 20.0 mg/mL Fluorouracil 50.0 mg/mL Methotrexate 25 mg/mL Paclitaxel (Taxol) 6.0 mg/mL Thiotepa 10.0 mg/mL Vincristine Sulfate 1.0 mg/mL
Note that Carmustine(BCNU) and Thiotepa have low permeation times.
Fentayl tested as follows: Fentanyl citrate 100 mcg/2mL
Product codes
LZA, LZC, QDO
Device Description
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
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
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 D412-2006a (reapproved 2013) 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
- 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 delaved-type hypersensitivity
- ISO 10993-10 Biological evaluation of medical devices-Part 11 Tests for systemic toxicity
Key Metrics
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
March 11, 2019
Sri Trang Gloves (Thailand) Co., LTD % M. Jordan Smith Quality Assurance and Regulatory Affairs Leader Sri Trang USA DBA Ventyv 5401 West Kennedy Boulevard, Suite 760 Tampa, Florida 33609-2447
Re: K182241
Trade/Device Name: Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA,LZC, QDO Dated: February 14, 2019 Received: February 14, 2019
Dear M. Jordan Smith:
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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elizabeth F. Claverie -S
Digitally signed by Elizabeth F. Claverie -S Date: 2019.03.11 00:18:52 -04'00'
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K182241
Device Name
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
Indications for Use (Describe)
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs are as follows:
- Carmustine (BCNU) 3.3 mg/mL Cisplatin 1.0 mg/mL Cyclophosphamide (Cytoxan) 20 mg/mL Dacarbazine (DTIC) 10.0 mg/mL Doxorubicin Hydrochloride 2.0 mg/mL Etoposide (Toposar) 20.0 mg/mL Fluorouracil 50.0 mg/mL Methotrexate 25 mg/mL Paclitaxel (Taxol) 6.0 mg/mL Thiotepa 10.0 mg/mL Vincristine Sulfate 1.0 mg/mL
Note that Carmustine(BCNU) and Thiotepa have low permeation times.
Fentayl tested as follows: Fentanyl citrate 100 mcg/2mL
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 [As Required by 21 section 807.92 (c)] K182241
Summary prepared: February 27, 2019
Sri Trang Gloves (Thailand) CO., LTD 10 Soi 10 Phetkasem Rd. Hatyai Songkhla. Thailand 90110 Phone: (+66) 74 344 663 Fax: (+66) 74 344 677 Contact Person - Mr. Anan Pruksanusak, Managing Director
Official Correspondent: Sri Trang USA DBA Ventyv™ 5401 West Kennedy Boulevard, Suite 760 Tampa, Florida 33609-2447 Phone: +1 (813) 606-4301 Fax: +1 (813) 606-4314 Contact person - Mr. M. Jordan Smith, Quality Assurance and Regulatory Affairs Leader
Device Trade or Proprietary Name - Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
Device Common or Usual Name - Examination glove
Device Classification Name - Nitrile Patient Examination Glove (21 CFR 880.6250)
Device Product Codes - LZA, LZC, QDO
Device Class - Class I
Description of the Device - Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs.
4
Intended Use of the Device – This device is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
| | TECHNOLOGICAL
CHARACTERISTICS | STANDARD | PREDICATE
DEVICE
K083755 | SUBJECT
DEVICE K182241 | COMPARISON |
|------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------|
| Indications for Use | N/A | This device is a
disposable device
intended for medical
purpose that is worn
on the examiner's
hand to prevent
contamination
between patient and
examiner.
The chemotherapy
drugs tested are as
follows:
Amethopterin
Hydrate
(Methotrexate),
Cisplatin,
Cyclphoshamide
(Cytoxan),
Dacarbazine (DTIC),
Doxorubicin
Hydrochloride,
Etoposide (Toposar),
5-Fluoruracil,
Paclitazel (Taxol),
and Vincristine
Sulfate | This device is a
disposable device
intended for medical
purpose that is worn
on the examiner's
hand to prevent
contamination
between patient and
examiner.
The tested
chemotherapy drugs
are as follows:
Carmustine (BCNU)
Cisplatin,
Cyclophosphamide,
Dacarbzine (DTIC),
Doxorubicin
Hydrochloride,
Etoposide (Toposar),
Fluorouracil,
Methotrexate,
Paclitaxel (Taxol),
Thiotepa,
Vincristine Sulfate
Note Carmustine
(BCNU) and
Thiotepa have low
permeation times
Fentanyl tested as
follows:
Fentanyl Citrate | Nearly Identical | |
| Dimensions: overall
length | Minimum 230
mm | 244 mm | 238 mm
238 mm | Identical | |
| | ASTM-D
6319 | 242 mm
242 mm | 238 mm | | |
| Dimensions: width
(mean) | 110 $ \pm $ 10 mm
ASTM-D
6319 | Size Large
113 mm
114 mm
114 mm | Size Large
114 mm
115 mm
114 mm | Identical | |
| Dimensions: palm and
finger thickness | Minimum
0.05 mm
ASTM-D
6319 | Palm
0.06 mm
0.07 mm
0.07 mm
Finger
0.09 mm
0.07 mm
0.08 mm | Palm
0.07 mm
0.07 mm
0.07 mm
Finger
0.08 mm
0.08 mm
0.09 mm | Identical | |
| Tensile strength: before
and after aging | Greater than
14 MPa
ASTM-D
6319 | Before
40 MPa
40 MPa
41 MPa
After
39 MPa
40 MPa
41 MPa | Before
35 MPa
33 MPa
35 MPa
After
31 MPa
32 MPa
34 MPa | Identical | |
| Ultimate elongation:
before and after aging | Greater than
500% Before,
400% After
ASTM-D
6319 | Before
564%
584%
580%
After
580%
580%
616% | Before
538%
534%
535%
After
518%
493%
503% | Identical | |
| Freedom from holes:
pinholes AQL 2.5 | Inspection
G1, AQL 2.5
7 Accept
8 Reject
ASTM-D
6319 | 3
2
3 | 0
2
0 | Identical | |
| | ASTM-D | 0.5 mg/glove | 0.7 mg/glove | | |
| Powder Free Residue | 6319 | 0.3 mg/glove
0.2 mg/glove | 0.8 mg/glove
0.8 mg/glove | Identical | |
| | ISO 10993-5
In vitro
cytotoxicity | N/A | Under the conditions
of the study, the
device extract was
found to be
cytotoxic and
therefore the device
extracts were
evaluated by ISO
10993-11 - Test for
systemic toxicity.
From the Acute
Systemic Toxicity
device extracts, the
device extracts did
not elicit a systemic
response in the
animal model. | Identical | |
| | ISO 10993-11
Tests for
systemic
toxicity | | | | |
| Biocompatibility | ISO 10993-10
Primary Skin
Irritation in
Rabbits | Under the conditions
of the study, the polar
and non-polar device
extracts were found
not to be an irritant to
the animal model. | Under the conditions
of the study, the
polar and non-polar
device extracts were
found not to be an
irritant to the animal
model. | Same | |
| | Guinea Pig
Sensitization | Under the conditions
of the study, the polar
and non-polar device
extracts were found
not to be sensitizers
to the animal model. | Under the conditions
of the study, the
polar and non-polar
device extracts were
found not to be
sensitizers to the
animal model. | Same | |
Technological Characteristics Comparison Table –
5
6
7
Summary of Non-Clinical Performance Testing - 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 D412-2006a (reapproved 2013) 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
- 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 . delaved-type hypersensitivity
- ISO 10993-10 Biological evaluation of medical devices-Part 11 Tests for systemic toxicity
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.