(90 days)
Not Found
No
The device description and intended use clearly define the device as a disposable nitrile glove for barrier protection, with no mention of AI or ML capabilities.
No.
The document explicitly states the device is a glove for preventing contamination, not for treating any medical condition.
No
Explanation: The device is a nitrile glove used as a barrier to prevent contamination, not for diagnosing any condition.
No
The device description clearly states it is a physical glove made of nitrile rubber, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be 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 clearly states it's a glove for providing a barrier against potentially infectious materials.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not perform any of those functions.
N/A
Intended Use / Indications for Use
The Nitrile Glove Powder Free Blue 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 (comma separated list FDA assigned to the subject device)
LZA
Device Description
The proposed device is powder free, non-sterile nitrile examination gloves.
Following FDA Code LZA, a "nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants."
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 (medical purposes)
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 meets all design specifications, the FDA-recognized consensus standard, proposed labeling claims and pinhole acceptable quality level (AQL).
Relevant Standards and Test Results:
- ISO 10993-5 Biological evaluation of medical devices Test for in vitro cytotoxicity: Purpose - To determine the potential cytotoxicity. Acceptance Criteria - Non-cytotoxic. Results - PASS.
- ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for Systemic Toxicity: Purpose - To determine the potential systemic toxicity. Acceptance Criteria - Does not cause systemic toxicity. Results - PASS.
- ISO 10993-10 Biological evaluation on medical device Part 10: Test for Irritation and Skin Irritation: Purpose - To determine the potential for irritation and skin irritation. Acceptance Criteria - Non-irritant, and Non skin irritant. Results - PASS.
- ISO 10993-10 Biological evaluation on medical device Part 10: Test Skin Sensitization: Purpose - To determine the potential skin sensitization. Acceptance Criteria - Does not cause skin sensitization. Results - PASS.
- ASTM D6319, Standard Specification for Nitrile Examination Gloves for Medical Application: Purpose - To test for: (1) freedom from holes (2) physical dimensions (3) Aging. Acceptance Criteria - (1) Shall not leak (2) For size M (mm): Width: 110 +/- 10 Length: >= 230 Finger and palm thickness: median value >= 0.05 (3) After Aging: Tensile Strength: >= 14 MPa Ultimate elongation: >= 400%. Results - PASS.
- EN 455-1, EN 455-2, Medical Gloves For Single Use: Purpose - To test for: (1) freedom from holes (2) dimensions and strength. Acceptance Criteria - (1) Shall not leak (2) For size M (mm): Width: 110 Length: >= 240 Strength: Force at Break: >= 6N Force at break after challenge testing >= 6N at 7 days. Results - PASS.
Clinical testing was not required to support this device.
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.
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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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 21, 2021
Changzhou Universal Medical Equipment CO. LTD. % Roxanne Dubois Regulatory Consultant R. Dubois Consulting, LLC 1399 Robnick Ct. Campbell, California 95008
Re: K210145
Trade/Device Name: Nitrile Glove Powder Free Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 31, 2021 Received: April 5, 2021
Dear Roxanne Dubois:
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.
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
1
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 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 W. Murray, III Acting 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) K210145
Device Name
Nitrile Glove Powder Free Blue
Indications for Use (Describe)
The Nittile Glove Powder Free Blue is a disposable device intended 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for Changzhou Universal Medical Equipment Co., Ltd. The logo consists of a blue circular emblem with stars around the perimeter and Chinese characters inside. To the right of the emblem is the company name in both Chinese and English. The English translation reads "Changzhou Universal Medical Equipment Co., Ltd."
510(k) Summary - K210145
1.0 Submitter's Information:
| Name: | Changzhou Universal Medical Equipment Co. Ltd |
|---|---|
| Address: | No 6, Xinxi Road, Xinbei District |
| Changzhou, Jiangsu Province, 213000 China | |
| Tel: | +86-519-85483888 |
| Date of Preparation: | January 12, 2021 |
| Contact Person: | Roxanne Dubois |
| Address: | R. Dubois Consulting, LLC |
| 1399 Robnick Ct., Campbell, CA 95008 | |
| Tel: | 408-828-5019 |
| Email: | rduboisconsulting@gmail.com |
2.0 Device Information
| Trade name: | Nitrile Glove Powder Free Blue |
|---|---|
| Common name: | Patient Examination Gloves |
| Regulation name: | Non-powdered patient examination glove |
3.0 Classification
| Production code: | LZA |
|---|---|
| Regulation number: | 21 CFR 880.6250 |
| Classification: | Class I |
| Panel: | General Hospital |
4.0 Predicate Device Information
| Manufacturer: | Haining Medical Products Co. Ltd |
|---|---|
| Device: | Nitrile Glove Powder Free White |
| 510(k) number: | K183068 |
5.0 Indications for Use
The Nitrile Glove Powder Free Blue is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device Description
The proposed device is powder free, non-sterile nitrile examination gloves.
Following FDA Code LZA, a "nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants."
4
7.0 Technological Characteristic Comparison Table
| Table 1 General Comparison |
|---|
| ---------------------------- |
| Topic | Proposed Device | Predicate Device
(K183068) | Comparison |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | LZA | LZA | Same |
| Regulation No | 21 CFR 880.6250
Non-powdered patient
examination glove | 21 CFR 880.6250
Non-powdered patient
examination glove | Same |
| 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 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. | Same |
| Class | Class I reserved medical
devices that require a 510(k)
premarket notification | Class I reserved medical devices
that require a 510(k) premarket
notification. | Same |
| Indications For Use | The Nitrile Glove Powder
Free Blue is a disposable
device intended for medical
purposes that is worn on the
examiner's hands to prevent
contamination
between patient and examiner. | The Nitrile Glove Powder Free
Blue 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 Powder
Free | Non-powdered | Non-powdered | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use indication,
powder free, device color,
device name, glove size
and quantity, Nitrile Glove
Powder-Free, Non Sterile | Single-use indication, powder
free, device color, device
name, glove size and quantity,
Nitrile Glove Powder-Free,
Non Sterile | Same |
| Dimensions | Length:
230 mm
Width:
85-115 mm
Thickness:
0.05 mm | Length:
230 mm
Width:
85-115 mm
Thickness: 0.05 mm | Same |
| Colorant | Blue | White | Different |
8.0 Discussion of Non-clinical and Performance Testing
Non-clinical tests were conducted to verify that the proposed device meets all design specifications, the FDA-recognized consensus standard, proposed labeling claims and pinhole acceptable quality level (AQL). The relevant standards and test results are provided below.
5
Table 2 Relevant Standards and Test Results
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5 Biological | |||
| evaluation of medical | |||
| devices Test for in vitro | |||
| cytotoxicity | To determine the | ||
| potential | |||
| cytotoxicity. | Non-cytotoxic | PASS | |
| ISO 10993-11 Biological | |||
| evaluation of medical | |||
| devices Part 11: Tests for | |||
| Systemic Toxicity | To determine the | ||
| potential systemic | |||
| toxicity. | Does not cause systemic toxicity | PASS | |
| ISO 10993-10 Biological | |||
| evaluation on medical | |||
| device Part 10: Test for | |||
| Irritation and Skin | |||
| Irritation | To determine the | ||
| potential for | |||
| irritation and skin | |||
| irritation. | Non-irritant, and | ||
| Non skin irritant | PASS | ||
| ISO 10993-10 Biological | |||
| evaluation on medical | |||
| device Part 10: Test Skin | |||
| Sensitization | To determine the | ||
| potential skin | |||
| sensitization. | Does not cause skin sensitization | PASS | |
| ASTM D6319, Standard | |||
| Specification for Nitrile | |||
| Examination Gloves for | |||
| Medical Application | To test for: | ||
| (1) freedom from | |||
| holes | |||
| (2) physical | |||
| dimensions | |||
| (3) Aging | (1) Shall not leak | ||
| (2) For size M (mm): | |||
| Width: 110 +/- 10 | |||
| Length: $≥$ 230 | |||
| Finger and palm thickness: | |||
| median value $≥$ 0.05 | |||
| (3) After Aging: | |||
| Tensile Strength: $≥$ 14 MPa | |||
| Ultimate elongation: $≥$ 400% | PASS | ||
| EN 455-1, EN 455-2, | |||
| Medical Gloves For | |||
| Single Use | To test for: | ||
| (1) freedom from | |||
| holes | |||
| (2) dimensions and | |||
| strength | (1) Shall not leak | ||
| (2) For size M (mm): | |||
| Width: 110 | |||
| Length: $≥$ 240 | |||
| Strength: | |||
| Force at Break: $≥$ 6N | |||
| Force at break after challenge | |||
| testing $≥$ 6N at 7 days | PASS |
9.0 Discussion of Clinical Testing
Clinical testing was not required to support this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the predicate device.