(82 days)
Not Found
No
The device description and performance studies focus on the physical properties and chemical resistance of the gloves, with no mention of AI or ML technology.
No.
The device is a glove intended to prevent contamination between patient and examiner, not to provide therapy or treatment.
No
Explanation: The device is a glove intended to prevent contamination between the patient and examiner, not to diagnose a condition.
No
The device is a physical glove, not software. The description details its material, testing, and physical characteristics.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The description clearly states the glove is a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." Its primary function is a barrier to prevent the spread of contamination.
- Lack of Diagnostic Testing: There is no mention of the glove being used to perform any kind of test on a patient sample to diagnose or monitor a condition. The testing mentioned (ASTM D6978-05(2019), ASTM D6319-19, etc.) relates to the glove's physical properties, barrier function, and safety, not its ability to perform a diagnostic test.
Therefore, based on the provided information, the device is a medical glove used for protection and is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, ODO, OPJ
Device Description
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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. The device was tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). It also meets the specifications of ASTM D6319-19 for dimensions. Biocompatibility testing included In vitro Cytotoxicity ISO 10993-5, Acute Systemic Toxicity Test ISO 10993-11, Dermal Sensitization ISO 10993-10, and Primary Skin Irritation ISO 10993-23. All test results meet the requirements.
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
April 2, 2024
Syntex Healthcare Products Co., Ltd. Zhiqiang Qiao General Manager No. 1, Fanjiazhuang Industrial Zone Xinji, Hebei 052360 China
Re: K240080
Trade/Device Name: Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: January 10, 2024 Received: January 11, 2024
Dear Zhiqiang Oiao:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240080
Device Name
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentany) Citrate
Indications for Use (Describe)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentany] Citrate using ASTM D6978-05(2019) The following chemicals have been tested with these gloves:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 21.2 |
| Cisplatin, 1mg/ml (1000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil (5 Flu), 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500 ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 24.9 |
| Vincristine sulfate, 1mg/ml (1000 ppm) | >240 |
| Fentanyl Citrate | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 21.2 minutes, Thio Tepa: 24.9minutes
Warning: Do not use with Carmustine and Thiotepa.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
The assigned 510(K) numbers: K240080
Date Prepared: March 14, 2024
1. Owner's Identification:
Syntex Healthcare Products Co., Ltd No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China Contact: Mr. Qiao Zhiqiang / General Manager Tel:86-311-66179668 Email: fdareg@hongray.com.cn or janicema(@hongrayusa.com
2. Device Identification:
Trade / Product Name: Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Exam Gloves Classification Name: Non-powdered patient examination glove Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, ODO, OPJ Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Ansell Healthcare Products LLC. Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K200671) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. Product Code: LZA, LZC, QDO
4. Device Description:
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentary) Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
5. Indications for Use:
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019) The following chemicals have been tested with these gloves:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 21.2 |
| Cisplatin, 1mg/ml (1000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
6
| Fluorouracil (5 Flu), 50mg/ml (50,000ppm) | >240 |
|---|---|
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500 ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 24.9 |
| Vincristine sulfate, 1mg/ml (1000 ppm) | >240 |
| Fentanyl Citrate | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 21.2 minutes, Thiotepa: 24.9 minutes
Warning: Do not use with Carmustine and Thiotepa.
6. Comparison of Subject Device and Predicate Device:
The following tables are summaries of the technological characteristics, biocompatibility and testing for use with chemotherapy drugs & Fentanyl Citrate of the subject and predicate devices. General Comparison Table:
| Characteristics and
Parameters | Subject Device
K240080 | Predicate Device
K200671 | Comparison
Result |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Trade Name | Aloe Vera Nitrile Examination Gloves
(Green) Tested for Use with
Chemotherapy Drugs and Fentanyl
Citrate | Microflex® Nitrile Patient
Examination Gloves with Aloe and
Chamomile Pink Colored Tested for
Use with Chemotherapy Drugs and
Fentanyl Citrate | Different* |
| Product Code | LZA, LZC, QDO,OPJ | LZA, LZC,QDO | Different** |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | The glove is a disposable device
intended for medical purposes that is
worn on the examiner's hand to
prevent contamination between
patient and examiner.
Gloves have been tested for use with
chemotherapy drugs and Fentanyl
Citrate using ASTM D6978-05(2019) | The glove is a disposable device
intended for medical purposes that is
worn on the examiner's hand to
prevent contamination between
patient and examiner.
The gloves have been tested for use with
chemotherapy drugs and Fentanyl
Citrate using ASTM D6978-05(2019) | Same |
| Material | Synthetic nitrile rubber | Synthetic nitrile rubber | Same |
| Color | Green | Pink | Different*** |
| Design | • Single Use
• Non-sterile
• Powder-Free
• Ambidextrous
• Beaded cuff | • Single Use
• Non-sterile
• Powder-Free
• Ambidextrous
• Beaded cuff | Same |
| Chemotherapy Drugs
and Fentanyl Citrate
Claim | See below comparison table | See below comparison table | / |
7
| Aloe | Aloe coated on the donning surface | Aloe and Chamomile coated on the donning surface | Same |
|---|---|---|---|
| ------ | ------------------------------------ | -------------------------------------------------- | ------ |
- The trade name will be provided on the labeling, so the different does not raise any safety concerns.
** QDO and OPJ, both designated for Medical Gloves with Fentanyl Labeling Claims - Test For Use With Fentanyl, the subject device added the product code OPJ as per requirements but does not raise questions of safety and effectiveness.
*** The finished subject device has been tested with performance and Biocompatibility, all the test results meet the requirements, so the difference of color does not raise questions of safety and effectiveness.
Technological Characteristic Comparison Table:
| Technological Characteristics | Subject Device
K240080 | Predicate Device
K200671 | Comparison
Result |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Length | Minimum
XS: ≥ 220 mm
S: ≥ 220 mm
M: ≥ 230 mm
L: ≥ 230 mm
XL: ≥ 230 mm
XXL: ≥ 230 mm | Minimum
XS: ≥ 220 mm
S: ≥ 220 mm
M: ≥ 230 mm
L: ≥ 230 mm
XL: ≥ 230 mm | Similar* |
| Palm Width (size) (mm) | | | |
| XS | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | Same |
| XXL | 130±10 | / | Different* |
| Thickness (mm) (Minimum) | | | |
| Finger | 0.05 | 0.05 | Same |
| Palm | 0.05 | 0.05 | Same |
| Tensile Strength, Before Aging,
min | 14MPa | 16MPa | Similar* |
| Ultimate Elongation,
Before Aging, min | 500% | 500% | Same |
| Tensile Strength, After
Accelerated Aging, min | 14MPa | 14MPa | Same |
| Ultimate Elongation, After
Accelerated Aging, min | 400% | 400% | Same |
| Freedom from holes | | | Meet ASTM
D6319 and
similar |
| | G-I, AQL 2.5 | G-I, AQL 2.5 | |
| Powder residual | Residual Powder: ≤ 2 mg per
glove | Residual Powder: ≤ 2 mg per
glove | Same |
| In vitro Cytotoxicity
ISO 10993-5 | Under the conditions of this study,
the test article showed potential
toxicity to L929 cells. | Under the conditions of the
study, undiluted, 1:2, 1:4, 1:8,
1:16 dilution was cytotoxic., 1:32
and 1:64 are not cytotoxic | Same |
8
| Acute Systemic Toxicity Test
| ISO 10993-11 | Under the conditions of this study, there was no evidence of acute systemic toxicity from the test article. | Under the conditions of the study, no evidence of acute systemic toxicity | Same |
|---|---|---|---|
| Dermal Sensitization | |||
| ISO 10993-10 | Under the conditions of this study, the test article showed no evidence of causing skin sensitization | Under the conditions of the study, not a sensitizer | Same |
| Primary Skin Irritation | |||
| ISO 10993-23 | The test result showed that the response of the test article was categorized as negligible under the test condition. | Under the conditions of the study, not an irritant | Same |
*The subject device has Size XXL and the predicate device has not size XXL, but the subject device has been tested according to ASTM D6319-19 for dimensions meet the requirements of ASTM D6319-19. It can demonstrate the effectiveness of the subject device.
Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drug and Concentration | Minimum BDT (Minutes) | | Comparison
Result |
|--------------------------------------------|---------------------------|-----------------------------|----------------------|
| | Subject Device
K240080 | Predicate Device
K200671 | |
| Carmustine 3.3 mg/ml (3,300 ppm) | 21.2 | 23.4 | Similar * |
| Cisplatin, 1mg/ml (1000 ppm) | >240 | / | Different* |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | Same |
| Dacarbazine, 10 mg/ml (10,000 ppm) | >240 | / | Different* |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | Same |
| Fluorouracil (5 Flu), 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | Same |
| Mitomycin C, 0.5mg/ml (500 ppm) | >240 | / | Different* |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 24.9 | 64.9 | Similar* |
| Vincristine sulfate, 1mg/ml (1000 ppm) | >240 | >240 | Same |
| | Minimum BDT (Minutes) | | |
| Fentanyl Citrate | Subject Device
K240080 | Predicate Device
K200671 | Comparison
Result |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | Same |
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this difference and similar does not raise questions of safety and effectiveness of subject device.
7. Clinical Performance Data
Not applicable.
8. Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.