(251 days)
No
The device is a standard patient examination glove and the summary does not mention any AI or ML capabilities.
No
The device is a patient examination glove, intended to prevent contamination, not to provide therapy.
No
This device, a patient examination glove, is intended to prevent contamination between patient and examiner. Its purpose is protective, not diagnostic.
No
The device is a physical patient examination glove, not a software application. The description focuses on material properties and physical testing.
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 a "patient examination glove" worn on the hands to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description classifies it as a Class I device under the General and Plastic Surgery Device panel, specifically for patient examination gloves. This classification is for devices used in surgical or examination settings, not for in vitro diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Providing diagnostic information about a patient's condition
- Use of reagents or analytical methods
The device's function is purely protective and preventative through physical means.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirement of ASTM Standard D5250-06.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's, 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)
The standards used for Zibo Intco Medical Products. Co. Ltd. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2. AQL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5. Inspection Level I, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
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.
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
510 (K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.
-
- Submitter's Identification:
Zibo Intco Medical Products, Co. Ltd. No. 18, Qingtian Road. Qilu Chemical Industry Park Zibo. Shandong Province China
- Submitter's Identification:
Date summary prepared: March 23, 2014
-
- Name of the Device:
Zibo Intco Medical Products, Co. Ltd. Powder-free Vinyl Patient Examination Gloves. Yellow Color
- Name of the Device:
-
Common name/classification name of the Device: 3.
Powder-Free Vinyl Patient Examination Gloves, Yellow Color
4. Contact Person:
Jennifer Guo, Tel: 909-548-4828
Predicate Device Information: ಳು
Shijiazhuang Hongxiang Plastic Products Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)
Device Description: 6.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirement of ASTM Standard D5250-06.
-
- Intended Use:
A patient examination ylove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.
- Intended Use:
m
1
8. Comparison to Predicate Devices:
Zibo Intco Medical Products, Co. Ltd. Powder-free Vinyl Patient Examination Gloves, Yellow Color are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd. (K992821) and Shanghai Jiawang Industrial Co., Ltd. (K031854)
9. Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Zibo Intco Medical Products. Co. Ltd. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2. AQL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5. Inspection Level I, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
Discussion of Clinical Tests Performed: 10.
Not Applicable - There is no hypoallergenic claim.
11. Conclusions:
Zibo Intco Medical Products, Co. Ltd. Powder-free Vinyl Patient Examination Gloves. Yellow Color conform fully to ASTM-D-5250-06 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
2
| | Proposed Device | Predicate Device
(K992821) |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Description | Zibo Intco Medical Products, Co. Ltd
Powder-Free Vinyl Patient
Examination Gloves, Yellow Color | Shijiazhuang Hongxiang
Powder-free Vinyl Patient
Examination Gloves |
| Product Code | LYZ | LYZ |
| Indications for Use | A disposable device intended for
medical purposes that is worn upon the
examiner's hands or fingers to prevent
contamination between patient and
examiner. | Substantially equivalent |
| Type of Use | Over-The-Counter Use | Substantially equivalent |
| Labeling: Instruction
for use | A garment covering the hand and wrist
area. Clovers have separate openings
for each finger and the thumb. | Substantially equivalent |
| Labeling: Labels on
the carton | Labels include: Product name; color;
"single use Only" size, piece count, lot
number, distributor name. and
manufacturer address. | Substantially equivalent |
| Device Materials | Poly Vinyl Chloride
Polyurethane
Diisononyl Phthalate (DINP) | Substantially equivalent |
| Before Aging:
Tensile,
Strength(Mpa) and
Ultimate Elongations | Average Tensile Strength (Mpa): 19.2
Average Ultimate Elongations: 501% | Substantially equivalent |
| After Aging: Tensile
Strength(Mpa) and
Ultimate Elongations | Average Tensile Strength (Mpa): 16.8
Average Ultimate Elongations: 472% | Substantially equivalent |
| Overall Length on
Medium Size | Average over 249mm | Substantially equivalent |
| Width of Palm on
Medium Size | Average 95mm | Substantially equivalent |
| Palm Thickness | Average 0.085 mm | Substantially equivalent |
| Figure Thickness | Average 0.088 mm | Substantially equivalent |
| Residual Powder | According to ASTM D6124-06
Standard Test Method for Residual
Powder on Medical gloves for the
determination of residual powder
content. Testing result indicates the
weight of all types of residual or
powder on finished powder-free
gloves as