(99 days)
Not Found
No
The device is a physical product (examination gloves) and the summary describes its physical properties and biocompatibility testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device, examination gloves, are used to prevent contamination, not to treat a disease or condition.
No
The device is Nitrile Examination Gloves, which are used to prevent contamination between patient and examiner. They do not diagnose any condition or disease.
No
The device is a physical product (nitrile examination gloves) and the 510(k) summary describes its physical properties and performance testing, not software functionality.
No, 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 hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the material, color, size, and purpose of the gloves as a barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing information about a patient's health status.
- Performance Studies: The performance studies focus on physical properties (dimensions, strength, watertightness) and biocompatibility (skin irritation, sensitization, toxicity), which are relevant for a medical device worn on the skin, but not for an IVD.
- Key Metrics: The listed "Key Metrics" are explicitly stated as "Not Applicable" in the context of diagnostic 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. These gloves do not perform any such function.
N/A
Intended Use / Indications for Use
Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are powder-free Class I patient examination gloves are manufactured from nitrile and are blue in color. The examination gloves are intended for medical purpose, will be worn on the examiner's hand, and will be available in four sizes (Small, Medium, Large, and Extra-Large).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
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 testing was performed based on the following standards and showed passing results:
- ASTM D 6319 Standard Specification for Nitrile Examination Gloves for Medical Application (Length, Width, Thickness, Tensile Strength, Ultimate Elongation)
- ASTM D 5151 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D 6124 Standard Test Method for Residual Powder on Medical Gloves
- Biocompatibility testing per ISO 10993-10 (Primary Skin Irritation, Dermal Sensitization), ISO 10993-5 (In Vitro Cytotoxicity), and ISO 10993-11 (Acute Systemic Toxicity Test)
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 contains 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 24, 2021
Beijing Reagent Latex Products Co., Ltd. % Stephen Beier Head of Regulatory Affairs and Quality Systems Bayside Life Science Consultants, LLC 252 Nassau Street, Floor 2 Princeton, New Jersey 08542
Re: K211515
Trade/Device Name: Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 21, 2021 Received: August 5, 2021
Dear Stephen Beier:
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.
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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 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 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211515
Device Name
Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves
Indications for Use (Describe)
Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand 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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510(k) Summary
(K211515)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Beijing Reagent Latex Products Co., Ltd. Address: No. 6 Xingguang 5th Street Opto-Mechatronics Industrial Park Beishenshu Village Est, Taihu Town Tongzhou District, Beijing, China 101111 Phone Number: +86-10-81502524 Contact: HaiTao Liu, Export Manager Date of Preparation: July.30,2021
Designated Submission Correspondent
Stephen Beier, Head of Regulatory Affairs & Quality Systems Bayside Life Science Consultants, LLC 252 Nassau Street, Floor 2 Princeton, NJ 08542 Tel: +1-800-881-2063 Email: stephen@baysideops.com
2.0 Device Information
Trade name: Snow Lotus Nitrile Examination Gloves Common name: Nitrile Examination Gloves Classification name: Non-powdered patient examination gloves Model(s): S, M, L, XL
3.0 Classification
Production code: LZA, Requlation number: 21 CFR 880,6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Beijing Reagent Latex Products Co., Ltd. Device: Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves 510(k) number: K211515
5.0 Device Description
The Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are powder-free Class I patient examination gloves are manufactured from nitrile and are blue in
4
color. The examination gloves are intended for medical purpose, will be worn on the examiner's hand, and will be available in four sizes (Small, Medium, Large, and Extra-Large).
6.0 Indication for Use
Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
| Item | Predicate Device
(K192333) | Subject Device
(K211515) | Remark |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Intended Use | Blue Nitrile Examination
Gloves Powder Free is
disposable device
intended for medical
purpose that are won
on the examiner's hand
to
prevent contamination
between patient and
examiner. | Beijing Reagent Latex
Products Co., Ltd Nitrile
Examination Gloves are
disposable devices
intended for medical
purpose that are worn on
the examiner's hand
to prevent contamination
between patient and
examiner. | Same |
| Dimensions
(Length and Width)
per ASTM D6319 | Length: Minimum 230
mm
Width: Minimum 95+/-
10mm (for medium sized
glove) | Length: Minimum 230 mm
Width: Minimum 95+/-
10mm (for medium sized
glove) | Same |
| Thickness per
ASTM D6319 | Palm thickness:
Minimum
0.05 mm
Finger thickness:
Minimum
0.05 mm | Palm thickness: Minimum
0.05 mm
Finger thickness: Minimum
0.05 mm | Same |
| Physical Properties
Before Aging per
ASTM D6319 | Tensile Strength:
Minimum 14 MPa
Ultimate Elongation:
Minimum 500% | Tensile Strength:
Minimum 14 MPa
Ultimate Elongation:
Minimum 500% | Same |
| Physical Properties
After Aging per
ASTM D6319 | Tensile Strength:
Minimum 14 MPa
Ultimate Elongation:
Minimum 400% | Tensile Strength:
Minimum 14 MPa
Ultimate Elongation:
Minimum 400% | Same |
| Water tight (hole
detection) per
ASTM D5151 | Passes at AQL of 2.5 | Passes at AQL of 2.5 | Same |
| Powder Residue
per ASTM D6319 | ≤ 2 mg/glove | ≤ 2 mg/glove | Same |
| Biocompatibility:
Primary Skin
Irritation per ISO
10993-10 | Not an irritant under the
conditions of the study. | Not an irritant under the
conditions of the study. | Same |
| Biocompatibility:
Dermal
Sensitization
per ISO 10993-10 | Not a sensitizer under
the
conditions of the study. | Not a sensitizer under the
conditions of the study. | Same |
| Biocompatibility: In
Vitro Cytotoxicity
per ISO 10993-5 | Under the conditions of
the study, cytotoxic.
Additional testing
performed to determine if
this was a systemic
toxicity concern. | Under the conditions of the
study, cytotoxic at
elevated test article
extracts. Additional
analysis was performed to
determine if this was a
systemic toxicity concern.
Non-cytotoxic at 25% test
article extract. | Similar |
| Biocompatibility:
Acute Systemic
Toxicity Test per
ISO 10993-11 | Device extracts do not
pose a systemic toxicity
concern under the
conditions of the study. | Device extracts do not
pose a systemic toxicity
concern under the
conditions of the study. | Same |
| Device Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Size Offering | Extra-Small, Small, | Small, Medium, Large, | Different |
| | Medium, Large, Extra-
Large | Extra- Large | (no Extra
Small size
offered) |
| Number of Uses | Single Use | Single Use | Same |
7.0 Technological Characteristic Comparison Table
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Analysis: There are no significant differences between the subject device and its predicate device, and the two are identical in terms of intended use, materials, design, and performance specifications. Both the predicate device under K192333 as well as the subject device are compliant with ASTM D6319.
8.0 Summary of Non-Clinical Testing
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D 6319 Standard | |||
| Specification for Nitrile | |||
| Examination Gloves for | |||
| Medical Application | ASTM D 6319 Standard | ||
| Specification for Nitrile | |||
| Examination Gloves for | |||
| Medical Application | Small: Min 220 mm | ||
| Medium: Min 230 mm | |||
| Large: Min 230 mm | |||
| Extra-Large: Min 230 mm | Pass | ||
| ASTM D 6319 Standard | |||
| Specification for Nitrile | |||
| Examination Gloves for | |||
| Medical Application | To determine the | ||
| width of the gloves. | Small: 80 ± 10 mm | ||
| Medium: 95 ± 10 mm | |||
| Large: 110 ± 10 mm | |||
| Extra-Large: 120 ± 10 mm | Pass |
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| ASTM D 6319 Standard
Specification for Nitrile
Examination Gloves for
Medical Application | To determine the
Thickness of the gloves. | Min palm thickness: 0.05 mm
Min finger thickness: 0.05 mm
(for all sizes) | Pass |
|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------|
| ASTM D 5151 Standard
Test Method for
Detection of Holes in
Medical Gloves | To determine the
presence of holes in
the gloves. | AQL = 2.5 | Glove
inspection
passes at an
AQL of 2.5 |
| ASTM D 6124 Standard
Test Method for
Residual Powder on
Medical Gloves | To determine the
residual powder
content on the
gloves. | ≤ 2 mg/glove | Pass |
| ASTM D 6319 Standard
Specification for Nitrile
Examination Gloves for
Medical Application | To determine the
tensile strength of the
gloves. | Before Aging
Minimum of 14 MPa for all Sizes
After Aging
Minimum of 14 Mpa for all sizes | Pass |
| ASTM D 6319 Standard
Specification for Nitrile
Examination Gloves for
Medical Application | To determine the
ultimate elongation of
the gloves. | Before Aging
Minimum of 500% for all sizes
After Aging
Minimum of 400% for all sizes | Pass |
| Biocompatibility:
Primary Skin Irritation
per ISO 10993-10 | To determine if the
finished device
material is an irritant. | Not an irritant under the
conditions of the study. | Pass |
| Biocompatibility:
Dermal Sensitization
per ISO 10993-10 | To determine if the
finished device
material is a sensitizer. | Not a sensitizer under the
conditions of the study. | Pass |
| Biocompatibility: In
Vitro Cytotoxicity per
ISO 10993-5 | To determine if the
finished device
material is cytotoxic. | Non-cytotoxic under the
conditions of the study. | noncytotoxic
at 25% test
article extract. |
| Biocompatibility: Acute
Systemic Toxicity Test
per ISO 10993-11 | To determine if the
finished device
material extracts
pose a systemic
toxicity concern | Device extracts do not pose a
systemic toxicity concern under
the conditions of the study. | Pass |
9.0 Summary of Clinical Testing
This section is not applicable to this Premarket Notification 510(k); there was no clinical testing conducted on this product.
10.0 Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K211515, Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under 510(k) K192333.