(122 days)
Not Found
No
The device is a disposable nitrile examination glove, and the description and testing focus on physical properties, biocompatibility, and freedom from holes, with no mention of AI/ML capabilities.
No.
The device is described as a disposable glove intended to prevent contamination, not to treat or alleviate a medical condition.
No
A diagnostic device is used to identify or detect a disease or condition. This device, a disposable nitrile examination glove, is intended for preventing contamination, not for diagnosis.
No
The device is a physical glove, not software. The description details material properties, physical tests, and biocompatibility, which are characteristic of a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description focuses on the physical properties and standards related to gloves (material, powder content, hole detection, dimensions, etc.).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical integrity, biocompatibility, and safety of the gloves as a barrier device, not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Dermoaroma Disposable Nitrile Examination Gloveare disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The proposed device is Powder Free Dermoaroma Disposable Nitrile Examination Glove. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
-
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- Purpose: This part of ISO 10993 assesses possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization.
- Acceptance Criteria: Skin Sensitization Test: provided grades less than 1, otherwise sensitization. Skin Irritation Test: If the primary irritation index is 0-0,4, the response category is Negligible. 0,5-1,9 means slight, 2-4,9 means moderate, 5-8 means severe.
- Results: All grades are 0. All animals were survived and no abnormal signs were observed during the study. The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition.
-
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- Purpose: This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices.
- Acceptance Criteria: The viab.% of the 100% extract of the test article is the final result, and if viability is reduced to
§ 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 27, 2021
ChuZhou Harmony Gloves Medical Technology Co.,Ltd Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K212716
Trade/Device Name: Dermoaroma Disposable Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 19, 2021 Received: November 29, 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); 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 mediation-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 Clarence W. 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212716
Device Name
Dermoaroma Disposable Nitrile Examination Glove
Indications for Use (Describe)
The Dermoaroma Disposable Nitrile Examination Gloveare disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
| 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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92(a)(1).
1.0 Submitter's information
Name: ChuZhou Harmony Gloves Medical Technology Co.,Ltd Address: Technology Road 6, branching stream economic development zone, LaiAn Town,Chuzhou City ,AnHui Province,China Phone Number: +86-18689321491 Contact: WeiHong Ou Date of Preparation: December 7, 2021
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Dermoaroma Disposable Nitrile Examination Glove Patient Examination Gloves Common name: Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
Manufacturer: Jiangxi Surefine Medical Co., Ltd. Blue Nitrile Exam Gloves Device: 510(k) number: K211341
4
5.0 Indications for Use
The Dermoaroma Disposable Nitrile Examination Glove are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device description
The proposed device is Powder Free Dermoaroma Disposable Nitrile Examination Glove. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
7.0 Summary comparing technological characteristics with predicate device
| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| 510(k) number | K212716 | K211341 | |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | The Dermoaroma Disposable Nitrile 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. | The Blue Nitrile Exam Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Dermoaroma Disposable Nitrile Examination Glove, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Blue Nitrile Exam Gloves, Non-Sterile | Same |
Table1-General Comparison
Table2 Device Dimensions Comparison
| Predicate | Designation | Size | Tolerance | |||
|---|---|---|---|---|---|---|
| Device(K211341) | S | M | L | XL |
5
| Length, mm | 220 | 230 | 230 | 230 | min | |
|---|---|---|---|---|---|---|
| Width, mm | 80 | 95 | 110 | 120 | ±10 | |
| Thickness, mm: | ||||||
| Finger | 0.05 | min | ||||
| Palm | 0.05 | min | ||||
| Proposed Device | Designation | Size | Tolerance | |||
| S | M | L | XL | |||
| Length, mm | 220 | 230 | 230 | 230 | min | |
| Width, mm | 80 | 95 | 110 | 120 | ±10 | |
| Thickness, mm: | ||||||
| Finger | 0.05 | min | ||||
| Palm | 0.05 | min | ||||
| Remark | Same |
Analysis1: The proposed device has same sizes to the predicate device, and all proposed devices are conducted the properties test, the test results shown that the sizes comply with the requirements of standard ASTM D6319-19, Standard Specification For Dermoaroma Disposable Nitrile Examination Glove For Medical Application.
| Item | Proposed device | Predicated device | Remark | |||
|---|---|---|---|---|---|---|
| Colorant | blue | Blue | SAME | |||
| Physical | ||||||
| Properties | Before | |||||
| Aging | Tensile | |||||
| Strength | 14MPa, min | 14MPa, min | SAME | |||
| Ultimate | ||||||
| Elongation | 500%min | 500%min | SAME | |||
| After | ||||||
| Aging | Tensile | |||||
| Strength | 14MPa, min | 14MPa, min | SAME | |||
| Ultimate | ||||||
| Elongation | 400%min | 400%min | SAME | |||
| Comply with ASTM D6319 | Comply with ASTM D6319 | Comply with ASTM D6319 | SAME | |||
| Freedom from Holes | Be free from holes | |||||
| when tested in | ||||||
| accordance with | ||||||
| ASTMD5151 | ||||||
| AQL=2.5 | Be free from holes when | |||||
| tested in accordance with | ||||||
| ASTMD5151 AQL=2.5 | SAME | |||||
| Powder Content | 0.13mg -0.16 mg | 0.03 mg | SIMILAR | |||
| Analysis2 |
Table3 Performance Comparison
Analysis2: The proposed device has different powder content to the predicate device, but the proposed device is conducted the biocompatibility and performance tests, the test results shown that the difference does not affect the safety and efficacy of proposed device.
6
| Item | Proposed device | Predicated device | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | SAME |
| Sensitization | Under conditions of the study, not a sensitizer. | |||
| Cytotoxicity | Under the conditions of the study, the device is potentially cytotoxic | Comply with ISO10993-5 | SIMILAR | |
| Systemic toxicity | Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. |
Biocompatibility Testing Comparison Table4
8.0 Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
| No. | Name of the Test
Methodology / Standard | Purpose | Acceptance Criteria | Results |
|-----|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | ISO 10993-10:2010
Biological Evaluation Of
Medical Devices - Part
10: Tests For Irritation
And Skin Sensitization. | This part of ISO
10993 assesses
possible contact
hazards from
chemicals
released from
medical devices, | Skin Sensitization
Test:
provided grades less than 1,
otherwise
sensitization. | All grades are 0.
All animals were survived and no
abnormal signs were observed
during the study. |
| 2 | | which may
produce skin and
mucosal irritation,
eye irritation or
skin sensitization. | Skin Irritation Test:
If the primary irritation
index is 0-0,4, the
response category is
Negligible.
0,5-1,9 means slight
2-4,9 means moderate
5-8 means severe | The primary irritation index is 0.
The response of the proposed
device was categorized as
negligible under the test
condition |
| | | | | |
| 3 | ISO 10993-5:2009
Biological Evaluation Of
Medical Devices - Part
5: Tests For In Vitro
Cytotoxicity | This part of ISO
10993 describes
test methods to
assess the in vitro
cytotoxicity of
medical devices. | The viab.% of the
100% extract of the
test article is the final
result, and if viability is
reduced to