(62 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No
The device is a glove for preventing contamination, not for treating a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. Its function is protective, not diagnostic.
No
The device is a physical medical glove, not a software application. The description focuses on material properties, physical dimensions, and performance testing related to a tangible product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The described device is a patient examination glove. Its primary function is to act as a barrier to prevent contamination between a patient and an examiner. It is a physical barrier worn on the hands.
- Lack of Specimen Analysis: The device does not involve the collection, preparation, or analysis of any human specimens. It is not used to test or analyze anything from the patient's body.
- Testing for Chemotherapy Permeation: While the gloves are tested for their ability to resist permeation by chemotherapy drugs, this testing is related to the protective barrier function of the glove, not to the diagnosis or analysis of a patient's condition.
The information provided clearly indicates the device is a medical glove used for protection during patient examination, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) 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 subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extralarge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands (worn on the examiner's hands)
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)
Biocompatibility Evaluation:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.
- Results: Under the conditions of the study, the device is a non-irritant and a non-sensitizer.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- Results: Under the conditions of the study, the device is not cytotoxic, did not show potential toxicity to L-929 cells.
Performance Testing (Bench):
- Physical performance qualities evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- Length: S: >=220 mm; M/L/XL: >=230 mm. Results: >230 (Pass)
- Width: S:80±10mm; M:95±10mm; L: 110±10mm; XL: 120±10mm. Results: S: 81-86, M: 93-99, L: 104-109, XL: 113-116 (Pass)
- Thickness: Finger: >=0.05mm; Palm: >=0.05mm. Results: Finger: 0.11-0.15mm, Palm: 0.08-0.15mm (Pass)
- Tensile Strength: Before Aging: >=14MPa. Results: 14.0-15.4 (Pass). After Aging: >=14MPa. Results: 14.0-15.0 (Pass). Note: The table also lists >=500% for after aging which seems to be a typo given the units, likely referring to elongation.
- Ultimate Elongation: Before Aging: >=500% (The table shows >=14MPa, but given the unit and common standards for elongation, it's inferred to be %). Results: 506-664 (Pass). After Aging: >=400%. Results: 420-511 (Pass).
- Watertightness Test for Detection of Holes per ASTM D5151-19.
- Acceptance Criteria: Meet the requirements of ASTM D5151 AQL 2.5. Results: 0/125 leaks (Pass).
- Powder Content per ASTM D6124-06 (Reapproved 2017).
- Acceptance Criteria: 240 minutes breakthrough time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Biocompatibility: Non-cytotoxic, non-irritant, non-sensitizer.
- Physical Properties (ASTM D6319-19):
- Length: Pass
- Width: Pass
- Thickness: Pass
- Tensile Strength: Pass
- Elongation: Pass
- Watertightness (ASTM D5151-19): AQL 2.5, 0/125 leaks (Pass)
- Powder Content (ASTM D6124-06): 240 minutes
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 4, 2021
Hengchang (Dongying) Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161 Lujiazui East Rd., Pudong Shanghai. 200120 China
Re: K211714
Trade/Device Name: Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: May 25, 2021 Received: June 3, 2021
Dear Boyle Wang:
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 and Part 809 ); medical device reporting (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.
Clarence Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211714
Device Name
Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 23.6 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 Minutes |
| Methotrexate | 25 mg/ml(25,000 ppm) | > 240 Minutes |
| Mitomycin C | 0.5 mg/ml(500 ppm) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 57.4 Minutes |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.6 Minutes Thio-Tepa 10.0 mg/ml 57.4 Minutes
Caution: Testing showed an average breakthrough time of 57.4 minutes with Thio-Tepa WARNING: Do not use with Carmustine
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.
3
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4
510(k) Summary (K211714)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Hengchang (Dongying) Medical Technology Co.,Ltd. Address: Room 101,Building 2,No.26 Xinghe Road,Niuzhuang Town,Dongying District,Dongying City,China. Phone Number: +86-18653343268 Contact: Li Jing Date of Preparation: Aug.4,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy Drugs) Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL
3.0_Classification
Production code: LZA,LZC Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
- Manufacturer: Medline Industries, Inc. Device: Medline Powder-Free Light Blue Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs)
5
510(k) number: K201390
5.0 Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extralarge.
6.0 Indication for Use_
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection
Time in Minutes |
|-------------------------------|------------------------|-------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 23.6 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide
(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | > 240 |
| Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 |
| Methotrexate | 25 mg/ml(25,000 ppm) | > 240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 57.4 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | > 240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.6 Minutes; Thio Tepa 10.0 mg/ml 57.4Minutes.
Caution: Testing showed an average breakthrough time of 57.4 minutes with Thio-Tepa WARNING: Do not use with Carmustine
7.0 Technological Characteristic Comparison Table
6
| Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Product Code | LZA,LZC | LZA,LZC | Same |
| 510(k) Reference | K211714 | K201390 | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | A patient examination glove | ||
| is a disposable device | |||
| intended for medical | |||
| purposes that is worn on the | |||
| examiner's hands to prevent | |||
| contamination between | |||
| patient and examiner. | |||
| These gloves were tested for | |||
| use with chemotherapy | |||
| drugs, per ASTM D6978-05 | |||
| Standard Practice for | |||
| Assessment of Resistance | |||
| of Medical Gloves to | |||
| Permeation by | |||
| Chemotherapy Drugs. | A patient examination glove | ||
| is a disposable device | |||
| intended for medical | |||
| purposes that is worn | |||
| on the examiner's hand to | |||
| prevent contamination | |||
| between patient and | |||
| examiner. | |||
| These gloves were tested for | |||
| usewith chemotherapy drugs | |||
| as per ASTM D6978- | |||
| 05(2019) Standard Practice | |||
| for Assessment of | |||
| Resistance of Medical | |||
| Gloves to Permeation by | |||
| Chemotherapy Drugs. | Same | ||
| Powdered or | |||
| Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterile vs Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Color | Blue | Light Blue | Different |
| Labeling Information | Single-use indication, | ||
| powder free, device color, | |||
| device name, glove size and | |||
| quantity,Non-Sterile, a | |||
| statement of standard | |||
| ASTM D6978-05 | |||
| compliance and a | |||
| summary of the testing | |||
| results. | Single-use indication, powder | ||
| free, device color, device | |||
| name, glove size and | |||
| quantity, Non-Sterile, a | |||
| statement of standard | |||
| ASTM D6978-05 | |||
| compliance and a summary | |||
| of the testing results. | Similar | ||
| Dimensions - Length | Complies with ASTM | ||
| D6319-19: | |||
| S: ≥220 mm; | |||
| M/L/XL: ≥230 mm. | Complies with ASTM D6319- | ||
| 19: ≥240 mm. | Similar | ||
| Dimensions - Width | Complies with ASTM | ||
| D6319-19: | |||
| S:80±10mm; | |||
| M:95±10mm; | |||
| L: 110±10mm; | Complies with ASTM D6319- | ||
| 19: | |||
| S:85±10mm; | |||
| M:95±10mm; | |||
| L: 105±10mm; | Similar |
7
| XL: 120±10mm; | XL: 115±10mm; | ||||
|---|---|---|---|---|---|
| Dimensions - | |||||
| Thickness | Complies with ASTM D6319-19 | ||||
| Palm:≥0.05mm | |||||
| Finger: ≥0.05mm | Complies with ASTM D6319-19 | ||||
| Palm:≥0.16mm | |||||
| Finger: ≥0.14mm | Similar | ||||
| Physical Properties - | |||||
| Tensile Strength | Complies with ASTM D6319-19: | ||||
| Before Aging: ≥14MPa | |||||
| After Aging: ≥500% | Complies with ASTM D6319-19: | ||||
| Before Aging: ≥17MPa | |||||
| After Aging: ≥500% | Similar | ||||
| Physical Properties - | |||||
| Elongation | Complies with ASTM D6319-19: | ||||
| Before Aging: ≥14MPa | |||||
| After Aging: ≥400% | Complies with ASTM D6319-19: | ||||
| Before Aging: ≥14MPa | |||||
| After Aging: ≥400% | Same | ||||
| Freedom from Holes | Complies with ASTM D6319-19 | ||||
| and ASTM D5151-19 | |||||
| G-1, AQL 2.5 | Complies with ASTM D6319-19 | ||||
| and ASTM D5151-19 | |||||
| G-1, AQL 2.5 | Same | ||||
| Powder Content | Complies with ASTM D6319-19, 240 | > 240 | Same | ||
| Cyclophosphamide 20 mg/ml | > 240 | > 240 | Same | ||
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 | > 240 | Same | ||
| Doxorubicin Hydrochloride, 2.0 | |||||
| mg/ml | > 240 | > 240 | Same | ||
| Etoposide (Toposar), 20.0 mg/ml | > 240 | > 240 | Same | ||
| Fluorouracil, 50.0 mg/ml | > 240 | > 240 | Same | ||
| Methotrexate 25 mg/ml | > 240 | > 240 | Same | ||
| Mitomycin C 0.5 mg/ml | > 240 | > 240 | Same | ||
| Paclitaxel, 6.0 mg/ml | > 240 | > 240 | Same | ||
| Thiotepa, 10.0 mg/ml | 57.4 | 43.7 | Different | ||
| Vincristine Sulfate 1.0 mg/ml | > 240 | > 240 | Same |
8
Analysis:
-
The physical properties are a little different with that of the predicate, but they all meet the requirements of ASTM D6319-19.
-
The color of the subject device is different with that of the predicate. The subject device was evaluated according to ISO 10993-1 standards, and there were no risks identified.
3: Breakthrough detection times of Carmustine (BCNU) and Thio Tepa are different. The IFU Statement has clearly defined on the labeling.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical | ||
| Dimensions Test | Length(mm): | ||
| S: ≥220 mm; | |||
| M/L/XL: ≥230 mm. | Length:>230 | ||
| Width(mm): | |||
| S:80±10mm; | |||
| M:95±10mm; | |||
| L: 110±10mm; | |||
| XL: 120±10mm. | Width: | ||
| S: 81-86 | |||
| M: 93-99 | |||
| L: 104-109 | |||
| XL: 113-116 | |||
| Thickness (mm): | |||
| Finger: ≥0.05 | |||
| Palm: ≥0.05 | |||
| Finger: 0.11-0.15 | |||
| Palm: 0.08-0.15 | |||
| Pass | |||
| ASTM D5151 | Watertightness | ||
| Test for | |||
| Detection of | |||
| Holes | Meet the requirements of | ||
| ASTM D5151 AQL 2.5 | 0/125 leaks | ||
| Pass | |||
| ASTM D6124 | Powder Content | Meet the requirements of | |
| ASTM D6124 |