(5 days)
Not Found
No
The device is a disposable examination glove, and the description and performance studies focus on physical and biocompatibility properties, with no mention of AI/ML.
No
The device is described as a disposable glove intended to prevent contamination, not to treat or cure a disease or condition.
No
The device is described as a disposable glove intended to prevent contamination, not to diagnose medical conditions.
No
The device is a physical product (gloves) and the summary describes physical and biological performance testing, not software validation.
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 device is "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details the physical characteristics of a glove.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the glove, not on diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform such a function.
N/A
Intended Use / Indications for Use
The 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.
Product codes
LZA
Device Description
The subject device is powder free nitrile examination gloves. The subject device is Pink/Cool Gary/Green/Rose Gold.
It can be available in four specifications: S,M,L and XL. The subject 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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
Test Method: ASTM D6319
Purpose: Physical Dimensions Test
Acceptance Criteria: Length (mm): S: ≥220; M/L/XL: ≥230; Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10. Thickness (mm): Finger: ≥0.05 Palm: ≥0.05
Results: Length(mm): >230/Pass; Width(mm): S: 84-89 /Pass M: 94-97/ Pass L: 104-111/ Pass XL:113-116/ Pass Thickness (mm): Finger: 0.12-0.14/Pass Palm: 0.11-0.13/Pass
Test Method: ASTM D5151
Purpose: Watertightness Test for Detection of Holes
Acceptance Criteria: Meet the requirements of ASTM D5151 AQL 2.5
Results: 0/125/Pass
Test Method: ASTM D6124
Purpose: Powder Content
Acceptance Criteria: Meet the requirements of ASTM D6124
§ 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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
October 1, 2022
Jiangsu Cureguard Glove Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 1801. No. 16 Lujiazui East Rd., Pudong Shanghai, Shanghai 200120 China
Re: K222937
Trade/Device Name: 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: September 26, 2022 Received: September 26, 2022
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.
Bifeng Qian.M.D.,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) K222937
Device Name Disposable Nitrile Examination Glove
Indications for Use (Describe)
The 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.
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
K222937 510(k) Summary
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Jiangsu Cureguard Glove Co., Ltd. No. 65 Shenzhen Road, The Economic Development Zone, Suqian, Jiangsu, 223800 Address: China. +86-13485097856 Phone Number: Contact: Guo Hua Date of Preparation: Sep 26, 2022
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: | Disposable Nitrile Examination Glove |
|---|---|
| Common name: | Patient Examination Gloves |
| 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: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422
5.0 Indication for Use
The 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.
4
6.0 Device Description
The subject device is powder free nitrile examination gloves. The subject device is Pink/Cool Gary/Green/Rose Gold.
It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device
(K222937) | Predicated Device
(K171422) | Remark |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The 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 Disposable Powder Free
Nitrile Examination Glove,
White/ Blue/ Black/ Pink Color
is a disposable device
intended for medical
purposes that is worn on the
examiner's hands to prevent
contamination between
patient and examiner. | Same |
| Material | Nitrile | Nitrile | Same |
| Powdered or
Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Pink/Cool Gary/Green/Rose
Gold | White/ Blue/ Black/ Pink | Different
Analysis 1 |
| Labeling Information | Single-use indication, powder
free, device color, device
name, glove size and
quantity, Non-Sterile | Single-use indication, powder
free, device color, device
name, glove size and
quantity, Non-Sterile | Same |
| Dimensions(mm) | Length:
S: ≥220;
M/L/XL: ≥230;
Width: | Length:
S/M/L/XL: ≥230;
Width:
XS: 75±5; | Different
Analysis 2 |
| | S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10. | S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5 | |
| Thickness(mm) | Finger: ≥0.05;
Palm: ≥0.05 | Finger: ≥0.05;
Palm: ≥0.05 | Same |
| | Tensile
Strength
14MPa, min | Tensile
Strength
14MPa, min | Same |
Table1-General Comparison
5
| | | Before
Aging | Ultimate
Elongation | 500% min | Ultimate
Elongation | 500% min | Same |
|------------------------|--------------------|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------------------------------------------------------------|------------|------|
| Physical
Properties | | After
Aging | Tensile
Strength | 14MPa, min | Tensile
Strength | 14MPa, min | Same |
| | | | Ultimate
Elongation | 400%min | Ultimate
Elongation | 400%min | 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 | | Meet the requirements of
ASTM D6124 | | Meet the requirements of
ASTM D6124 | | Same |
| | Biocompatibility | | ISO 10993-10;
Under the conditions of the
study, not an irritant or a
sensitizer | | ISO 10993-10;
Under the conditions of the
study, not an irritant or a
sensitizer | | Same |
| | | | ISO 10993-5
Under conditions of the study,
device extract is cytotoxic | | / | | / |
| | | | ISO 10993-11;
Under the
condition of acute
systemic toxicity test,
the test article did not
show acute systemic
toxicity in vivo | | / | | / |
Analysis 1: The subject device (Black/ Lavender/ Navy Blue/ Burgundy) has different color to the predicate device (White/ Blue/ Black/ Pink), but all proposed devices are conducted the biocompatibility test.
Analysis 2: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319.
8.0 Summary of Non-clinical Testing
6
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
| Test
| Method | Purpose | Acceptance Criteria | Results | |
|---|---|---|---|---|
| ASTM | ||||
| D6319 | Physical | |||
| Dimensions | ||||
| Test | Length (mm): | |||
| S: ≥220; | ||||
| M/L/XL: ≥230; | ||||
| Width (mm): | ||||
| S: 80±10; | ||||
| M: 95±10; | ||||
| L: 110±10; | ||||
| XL: 120±10. | ||||
| Thickness (mm): | ||||
| Finger: ≥0.05 | ||||
| Palm: ≥0.05 | Length(mm): |
230/Pass;
Width(mm):
S: 84-89 /Pass
M: 94-97/ Pass
L: 104-111/ Pass
XL:113-116/ Pass
Thickness (mm):
Finger:
0.12-0.14/Pass
Palm:
0.11-0.13/Pass | |
| ASTM
D5151 | Watertightness
Test for
Detection of
Holes | Meet the requirements of ASTM
D5151 AQL 2.5 | 0/125/Pass | |
| ASTM
D6124 | Powder
Content | Meet the requirements of ASTM
D6124