(73 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of a patient examination glove, with no mention of AI or ML.
No
The device, a patient examination glove, is intended for preventing contamination, not for treating or curing a disease or condition.
No
Explanation: The device is described as a "patient examination glove" used to prevent contamination between a patient and examiner. Its purpose is protective, not diagnostic.
No
The device description clearly identifies the device as a physical patient examination glove, which is a hardware component. The summary focuses on physical and performance testing of the glove itself.
No, 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 or fingers to prevent contamination between patient and examiner. This is a barrier device for physical protection.
- Device Description: It's classified as a Class I device under 21 CFR 880.6250, which is for "Patient Examination Gloves." This classification is for general medical devices, not IVDs.
- Lack of IVD Characteristics: The description and testing information do not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or other substances to perform a test.
The testing described focuses on the physical properties and safety of the glove as a barrier device (tensile strength, elongation, dimensions, pinholes, skin irritation).
Therefore, based on the provided information, this device is a medical device intended for physical protection and is not an In Vitro Diagnostic.
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 (21CFR 880.6250)
Prescription Use
Over the Counter Use
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LA, and meets all requirement of ASTM Standard D6319-10.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
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)
The standards used for Dehai (Shandong) Medical Gloves, Co., Ltd. glove production are based on ASTM-D-6319-10. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Lewell S-2 AOL 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 sensitize toa 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).
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
FEB 2 8 2013
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.
1. Submitter's Identification:
Dehai (Shandong) Medical Gloves, Co., Ltd. No. 216 Huangong Road Linzi District, Zibo, Shandong China
Contact Person: Ray Zhou Tel: 909-548-4828 Fax: 909-548-4807 Email: rayzhou@basicmedical.com
Date summary prepared: Feb. 5, 2013
2. Name of the Device:
Dehai (Shandong) Medical Gloves, Co., Ltd. Nitrile Examination Gloves - Powder Free, Blue Color
3. Predicate Device Information:
Tangshan Zhonghong Pulin Group Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free (K082598)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LA, and meets all requirement of ASTM Standard D6319-10.
ડ. Intended 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 (21CFR 880.6250)
1
6. Comparison to Predicate Devices:
Dehai (Shandong) Medical Gloves, Co., Ltd. powder-free nitrile examination gloves (subject device) and Tangshan Zhonghong Pulin Group Co., Ltd. powder-free nitrile examination glove (predicate device) are substantially equivalent in all technological characteristics, including tensile steength, p ultimate elongations size, thickness, residual powder and pinhole. (please kindly refer attached side-by-side comparison of intended use, design, material, physical, biocompatibility and performance testing, Table 7-2)
Discussion of Non-Clinical tests performed for Determination of 7. Substantial Equivalence are as follows:
The standards used for Dehai (Shandong) Medical Gloves, Co., Ltd. glove production are based on ASTM-D-6319-10. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Lewell S-2 AOL 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 sensitize toa 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: 8.
Not Applicable - There is no hypoallergenic claim.
9. Conclusions:
Dehai (Shandong) Medical Gloves, Co., Ltd. Nitrile Patient Examination Gloves, Powder-Free, Blue color, conform fully to ASTM-D-6319-10 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
Side-by-Side Comparison of Intended Use, Design, Material, Biocompatibility, and Performance Testing Table 7-2.
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| Description | Proposed Device | Predicate Device (K082598) |
|---|---|---|
| Dehai (Shandong) Medical Gloves, Co., Ltd. | ||
| Powder-Free Nitrile Examination Gloves, Blue color | Tangshan Zhonghong Pulin Group | |
| Co., Ltd. Powder Free Nitrile Patient | ||
| Examination Gloves | ||
| Labeling: Instruction | ||
| for use | A garment covering the hand and wrist area. | |
| Clovers have separate sheaths or 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 | Nitrile Latex (NBR) | |
| Sulfur | ||
| Accelerator, ZDBC | ||
| Zinc Oxide | ||
| Potassium Hydroxide | ||
| Titanium Dioxide and Stabilizer | Substantially equivalent | |
| Before Aging: Tensile | ||
| Strength(Mpa) and | ||
| Ultimate Elongations | Average Tensile Strength (Mpa): 29.00 | |
| Average Ultimate Elongations: 750% | Substantially equivalent | |
| After Aging: Tensile | ||
| Strength(Mpa) and | ||
| Ultimate Elongations | Average Tensile Strength (Mpa): 24.00 | |
| Average Ultimate Elongations: 700% | Substantially equivalent | |
| Overall Length on | ||
| Medium Size | Average over 230mm | Substantially equivalent |
| Width of Palm on | ||
| Medium Size | Average 95mm | Substantially equivalent |
| Film Thickness | Average 0.073 mm | Substantially equivalent |
| Figure Thickness | Average 0.090 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 |