(232 days)
Not Found
No
The device description and intended use clearly define a physical barrier (gloves) with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies focus on material properties and standards relevant to gloves.
No
The device, examination gloves, is intended to prevent contamination, not to treat or alleviate a medical condition.
No
The device, "Powder Free Nitrile Patient Examination Gloves, Blue Color," is described as a non-sterile disposable device worn on the examiner's hand to prevent contamination. Its intended use is for medical purposes and it does not involve diagnosing any condition.
No
The device is a physical examination glove, not a software application. The description clearly states it is a "non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for medical conditions.
- Device Description and Intended Use: The provided information clearly states that the device is a "Powder Free Nitrile Patient Examination Glove." Its intended use is to be "worn on the examiner's hand or finger to prevent contamination between patient and examiner."
- Function: The function of the glove is a physical barrier to prevent the transfer of contaminants. It does not perform any diagnostic testing on a sample from the patient.
The device is a medical device, specifically a Class I medical device (based on the typical classification of examination gloves), but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger 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 Nitrile Examination Gloves. The proposed device is blue. 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
hand or finger
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 met all design specifications. The test results demonstrated that the proposed device complies with the following standards: ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, ASTM D6124-06 (Reapproved 2017), ASTM D5151-19, ASTM D6319-10(Reapproved 2015).
Key results for the subject device:
Dimensions: Length ≥230mm, Width (Small: 75-90 mm, Medium: 88-102 mm, Large: 107-117mm, X large: 114-128 mm), Thickness (Fingertip: ≥0.08mm, Palm: ≥0.08mm).
Physical Properties: Tensile strength (Before & After aging): 17-24 MPa, Before aging Elongation: 540-610%, After aging Elongation: 460-570%.
Freedom from pinholes: 5 noncompliance is allowed for water leakage test (Inspection Level I, AQL2.5, and Accept/Reject criteria of 10/11).
Powder Residual: Mean: 0.1mg/pcs.
Biocompatibility: Passed Primary Skin Irritation in rabbits (ISO 10993-10: 2010-08-01), Passed Dermal sensitization in the guinea pig (ISO 10993-10: 2010-08-01), Non-cytotoxicity to L-929 cells (ISO 10993-5: 2009 for MTT assay), Passed Acute Systemic Toxicity Systemic injection in mice (ISO 10993-11:2017) with device extracts not posing a systemic toxicity concern.
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.
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.
November 2, 2021
Shandong Jieshi Medical Products Co.,Ltd Chu Xiaoan Official Correspondent Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang, Chaoyung District Beijing, 100121 China
Re: K210777
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: September 17, 2021 Received: October 19, 2021
Dear Chu Xiaoan:
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, PhD 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Powder Free Nitrile Patient Examination Gloves, Blue Color
Indications for Use (Describe)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger 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
K210777
This summary of 510(k) is being submitted in accordance with 21 CFR 807.
Premarket Notification [510(k)] Summary
1.0 Submitter:
Submitter's name: Shandong Jieshi Medical Products Co., Ltd Submitter's address: North Road, Fumin Avenue, Qinghe Street, Caoxian County, Heze City, Shandong Province, 274400,P.R. China Name of contact person: Mr. Li Biao Phone number: 0086-530-2061157 Date of preparation: 2021-11-01
2.0 Name of the Device
Proprietary/Trade name: Powder Free Nitrile Patient Examination Gloves, Blue Color Common Name: Patient Examination gloves Classification Name: Non-powdered Patient examination glove Device Classification: I Regulation: 21 CFR 880.6250 Panel: General Hospital Product Code: LZA
3.0 Predicate device
Device Name: Powder Free Nitrile Patient Examination Glove, Blue Color Company name: Tangshan Zhonghong Pulin Plastic Co., Ltd. 510(K) Number: K120970
4.0 Device Description:
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
5.0 Indications for Use Statement:
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
| Features & Description | Predicate Device (K120970) | Subject Device (K210777) | Result of Comparison |
|---|---|---|---|
| Product name | Powder Free Nitrile Patient Examination Glove, Blue Color | Powder Free Nitrile Patient Examination Gloves, Blue Color | Same |
| Regulation Number | 21CFR880.6250 | 21CFR880.6250 | Same |
| Product Code | LZA | LZA | Same |
| Color | Blue | Blue | Same |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | Same |
| Indications for Use | Powder Free Nitrile Patient Examination Glove, Blue Color 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. | Powder Free Nitrile Patient Examination Gloves, Blue Color 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 |
6.0 Technological Characteristic Comparison:
4
| Device Description
and Specifications | | Meets ASTM D6319-10 | Meets ASTM D6319-10
(Reapproved 2015) | | | Same |
|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--|-----------|
| Dimensions --Length
ILS-2 AQL4.0
(ASTMD 6319-10) | ≥230mm min | | 232 mm min for all sizes | | | Similar |
| Dimensions
-- Width
IL S-2 AQL4.0
(ASTM D6319-10) | Small
Medium
Large
X large | 70-90 mm
85-105mm
100-120mm
110-130 mm | Small
Medium
Large
X large | 75-90 mm
88-102 mm
107-117mm
114-128 mm | | Similar |
| Dimensions
--Thickness
IL S-2 AQL4.0
(ASTM D6319-10) | Finger 0.05mm min.
Palm 0.05mm min. | | Thickness (mm) min.
Finger 0.08
Palm 0.08 | | | Similar |
| Physical Properties
IL S-2 AQL4.0
(ASTM D D6319-
10) | Before aging/after aging Tensile
Strength≥ 14MPa
Before aging Elongation ≥500%
After aging Elongation ≥400% | | Before Aging Elongation (%):
540-610
After Aging Elongation (%):
460-570
Before Aging Tensile Strength
(MPa): 19-24
After Aging Tensile Strength
(MPa): 17-22 | | | Similar |
| Freedom from
Pinholes | Meets
• 21 CFR 800.20
• ASTM D6319-10 | | 1) Inspection Level I AQL2.5, and
Accept/Reject criteria of 10/11
2) Water leakage test: 5
noncompliance is allowed. | | | Similar |
| Inspection
Level
AQL2.5 | I | | | | | |
| Residual Powder
(ASTM D 6124-
06(Reaffirmation
2011)) | below 2mg of residual
powder | | 1) Checked on 5pcs
sub-samples (N=5).
2) Result as following:
Mean: 0.1mg/pcs | | | Similar |
| Materials used to
fabricate the devices | Nitrile | | Nitrile | | | Same |
| Single Patient Use | Single Patient Use | | Single Patient Use | | | Same |
| Biocompatibility | Under the conditions of this study,
the test article was a non- irritant or
non- sensitizer (ISO 10993-
10:2002/Amd.1:2006) | | Under the conditions of this study,
the test article was a non- irritant or
non- sensitizer (ISO 10993-10:
Third Edition 2010-08-01) | | | Similar |
| | N/A | | Cytotoxicity study meets ISO 10993-
5 Third edition 2009-06-01 | | | Different |
| | N/A | | Under the conditions of study, the
device extracts do not pose a
systemic toxicity concern (ISO
10993-11:2017) | | | Different |
| Labeling for the
legally marketed
device to which
substantial
equivalence is
claimed. | -Powder Free
-Patient Examination
Glove
-Single Use Only
- Manufactured For:
- Lot
-Blue color | | -Powder Free
-Patient Examination Glove
-Single Use Only - Manufactured For:
- Lot
-Blue color - Non sterile | | | Same |
5
7.0 Discussion of Non-clinical and Performance Testing
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 10993-5:2009 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 10993-11:2017 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 D6319-10(Reapproved 2015), Standard Specification for Nitrile Examination Gloves for Medical Application.
| Test Methodology | Purpose | Acceptance Criteria | Results | |
|---|---|---|---|---|
| ASTM D 6319- | ||||
| 06(Reapproved | ||||
| 2015). | Dimension | Length | ≥230mm | |
| Width | Small | 75-90 mm | ||
| Medium | 88-102 mm | |||
| Large | 107-117mm | |||
| X large | 114-128 mm | |||
| Thickness | Fingertip | ≥0.08mm | ||
| Palm | ≥0.08mm | |||
| ASTM D 6319- | ||||
| 06(Reapproved | ||||
| 2015). | Physical | |||
| Properties | Tensile strength | |||
| (Before & After | ||||
| aging) | ≥14MPa | 17-24 | ||
| Before aging | ||||
| Elongation | ≥500% | 540-610 | ||
| After aging | ||||
| Elongation | ≥400% | 460-570 | ||
| • 21 CFR 800.20 | ||||
| • ASTM D 6319- | ||||
| 06(Reapproved | ||||
| 2015). | ||||
| • ASTM D5151- | ||||
| 19 | Freedom from | |||
| pinholes | Water leakage test: | |||
| Inspection LevelI, AQL2.5, and | ||||
| Accept/Reject criteria of 10/11. | 5 | |||
| noncompliance | ||||
| is allowed. | ||||
| • ASTM D6319- | ||||
| 10(Reapproved |
-
| Powder
Residual | Meets