(157 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No.
The device (patient examination glove) is intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
Explanation: The device, a patient examination glove, is described for preventing contamination between patient and examiner. Its intended use and mechanism do not involve diagnosing any medical condition or obtaining diagnostic information.
No
The device is a physical examination glove, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for infection control, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and barrier function of the glove, referencing standards related to rubber examination gloves. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, assays, or any other elements typically associated with in vitro diagnostics.
- Anatomical Site: The anatomical site is the hand or finger, which is where the glove is worn, not where a biological sample is taken from.
In summary, the device is a medical device used for barrier protection during patient examinations, which falls under a different regulatory category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
A 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.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
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) / Not Found
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. The tests conducted were Biological Evaluation of Medical Devices - Part 10 (Tests For Irritation And Skin Sensitization) adhering to ISO 10993-10:2010, ASTM D6124-06 (Reapproved 2017) for Residual Powder on Medical Gloves, ASTM D5151-06 (Reapproved 2015) for Detection of Holes in Medical Gloves, and ASTM D3578 - 19 for Rubber Examination Gloves. All tests complied with their respective standards.
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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
April 8, 2022
Shandong Intco Medical Products Co, Ltd. % John Zhao Official Correspondent Intco Medical Industries, Inc. 805 Barrington Ave. Ontario, California 91764
Re: K213509
Trade/Device Name: Latex Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: March 8, 2022 Received: March 9, 2022
Dear John Zhao:
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, 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
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Indications for Use
510(k) Number (if known) K213509
Device Name Powder Free Latex Examination Glove
Indications for Use (Describe)
A 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.
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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Image /page/3/Picture/0 description: The image shows the logo for Shandong Intco Medical Products Co., Ltd. The logo includes a stylized blue graphic to the left of the company name. Below the company name is the address: 9888 Qiwang Road, Naoshan Industrial Park, Qingzhou, Shandong, 262500.
510(K) SUMMARY
1. Submitter's Identification:
Shandong Intco Medical Products Co, Itd. 9888 Qiwang Road, Naoshan Industrial Park, Qingzhou, Shandong, 262500 China
Contact Person :
Haisheng Yu Vice General Manager
Date summary prepared: Oct. 28, 2021
-
- Product Trade Name: Shandong Intco Medical Products Co., Ltd Latex Examination Gloves, Powder Free
-
- Device Classification Name: Patient Examination gloves (21 CFR 880.6250)
- Device Class: 4. Class I.
- Product Code: 5. LYY
- Predicate Devices: 6. K161833 – Careglove Global SDN BHD
7. Reason for 510(k) Submission:
New device.
8. Device Description:
Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
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9. Intended Use:
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
10. Technology Characteristic Comparison between the device and predicate device:
There is no difference in technology characteristic compared to the predicate device. Gloves are made from natural rubber latex compound. Non-Sterile, Powder Free Latex Examination Gloves has the below technological characteristic compared to ASTM or Equivalent standards.
| Characteristics
and Parameters | Powder Free
Latex
Examination
Glove | Powder Free
Latex
Examination
Glove (K161833) | Comparison |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | LYY | LYY | Same |
| Intended Use | A patient
examination glove
is a disposable
device intended
for medical
purposes that is
worn on the hand
or finger to
prevent
contamination
between patient
and examiner. | A patient
examination glove
is a disposable
device intended for
medical purposes
that is worn on the
hand or finger to
prevent
contamination
between patient and
examiner. | Same |
| Classification | Class I | Class I | Same |
| Raw Rubber
Material | Natural Rubber
Latex | Natural RubberLatex | Same |
| Color | No color pigment
added. Natural
White | No color pigment
added.Natural
White | Similar |
| Overall Length
Minimum230mm | Average: 247 mm | Meet ASTM D3578-
05 | Similar |
| Width
S: 75mm - 95mm; M: 85mm –
105mm; L:100mm- 120mm | Average:
S: 85mm
M:96 mm
L:104 mm: | S: 82mm - 87 mm M:
94mm - 97mm L: 102mm -
107mm | Similar |
| Palm Thickness (Minimum | Average: 0.122 mm | 0.12mm - 0.14 mm | Similar |
| 0.08mm) | | | |
| Finger Thickness (Minimum | Average:0.156 mm | 0.10 - 0.13 mm | Similar |
| 0.08mm) | | | |
| Tensile Strength (before age)
Minimum 18 MPa | Average: 26.17MPa | 21.18 - 26.17 MPa | Similar |
| Tensile Strength (After Age)
Minimum 14 MPa | Average: 24.82MPa | 18.28 - 23.88 MPa | Similar |
| Stress at 500% Elongation 5.5 MPa
Maximum | 4.99 MPa | 3.0 - 4.2 MPa | Similar |
| Ultimate Elongation before age
(Minimum 500%) | Average: 759.85% | 750.20% - 820.20% | Similar |
| Ultimate Elongation after age
(Minimum 400%) | Average: 678.62% | 550.40% - 700.50% | Similar |
| Freedom of Holes
Meet AQL 2.5 at G1 | Meet AQL 2.5 with G1 | Meet AQL 2.5 with G1. | Similar |
| Residual powder test | Average powder
residue for each
size: | Contained less than 2 mg/glove | Similar |
| (Less than 2mg/glove) | S: 0.43 mg/glove;
M 0.31 mg/glove;
L: 0.47 mg/glove | | |
| Protein Testing | S size: Less than 50
µg/dm2; M size: Less
than 50 µg/dm2; L size:
Less than 50 µg/dm2 | less than 50 µg/dm2 | Similar |
| Primary Skin Irritation | Under the conditions of
study, not an irritant | Under the conditions of study,
not an irritant | Same |
| Dermal Sensitization | Under the conditions
of study, not a sensitizer. | Under the conditions of study,
not a sensitizer. | Same |
| Acute Systemic Toxicity | Under the conditions of
the study, no evidence
of systemic toxicity
from the extract | Not available | Different |
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11. Non-clinical Testing Summary:
Provided below is a summary of the standards and the test methodology that the subject device met the specification and acceptance criteria of the subject device.
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Biological Evaluation | |||
| of Medical Devices - | |||
| Part 10 | Tests For Irritation And | ||
| Skin Sensitization. | ISO 10993-10:2010 | Complied with the | |
| standard | |||
| ASTM D6124-06 | |||
| (Reapproved 2017) | Standard Test Method for | ||
| Residual Powder on | |||
| Medical Gloves | ASTM D6124-06 | Complied with the | |
| standard | |||
| ASTM D5151- | |||
| 06(Reapproved2015) | Standard Test Method for | ||
| Detection of Holes in | |||
| Medical Gloves. | ASTM D5151-06 | Complied with the | |
| standard | |||
| ASTM D3578 - 19 | Standard Specification for | ||
| Rubber Examination | |||
| Gloves | ASTM D3578 - 19 | Complied with the | |
| standard |
12. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that Shandong Intco Medical Products Co., Ltd. Powder Free, Latex Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device.