(100 days)
The DHD MedShield is a single-patient-use device. The Intended Use of the device is to reduce the taste effect of Metered Dose Inhaler (MDI) drugs by covering the tongue in the taste sensor area.
The MedShield product reduces drug deposition in the tongue when used in conjunction with metered dose inhaler (MDI) medications. The device attaches to an MDI elbow and shields the tongue of the user from the medication spray. Drug that deposits on the device would otherwise be on the users tongue. Based on this, the taste effect of the medications is reduced. This simple device includes two different features. 1. The patient end of the device covers the tongue. The patient end may vary to maximize the comfort of a wide range of users. 2. The elbow end of the device includes a universal clip, which attaches the device to all MDI elbows. To satisfy the preferences of various customers, the force required to separate (or attach) the device to various elbows can be modified by adjusting the clip or modifying the taper around the clip. The MedShield product has been designed to conform with ASTM F963-92, "Standard Consumer Safety Specification on Toy Safety, under Section 4.6, Small Objects, specifically 4.6.2, Mouth-Actuated Toys, and CFR 16-1511.1, "Requirements For Pacifically, 1511.5 Structural integrity tests for Small Parts, 1511.5 (d), to ensure that the device does not present a choke hazard. The MedShield is designed for single patient use. Patients may be given the product for use either in a hospital or home environment for extended time periods. Recommendations for cleaning, in cases of extended time, are included in the instructions for use.
This K961455 submission describes the MedShield, a tongue cover or guard designed to reduce drug deposition on the tongue when used with Metered-Dose Inhalers (MDIs). The device functions by shielding the tongue from the medication spray, thereby reducing the taste effect of the medications. The data provided focuses on the physical and chemical integrity of the device material (Celcon M90 Acetal resin) rather than clinical performance metrics related to drug deposition or taste reduction.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Methodology |
|---|---|---|
| Device Safety | Small Objects (Choke Hazard): Conform to ASTM F963-92, Section 4.6.2 (Mouth-Actuated Toys), and CFR 16-1511.1, 1511.5(d) (Structural integrity for small parts). Ensure the device does not present a choke hazard. | The MedShield product has been designed to conform with ASTM F963-92, "Standard Consumer Safety Specification on Toy Safety, under Section 4.6, Small Objects, specifically 4.6.2, Mouth-Actuated Toys, and CFR 16-1511.1, "Requirements For Pacifically, 1511.5 Structural integrity tests for Small Parts, 1511.5 (d), to ensure that the device does not present a choke hazard." (Statement of Conformance without specific test results provided in this document). |
| Material Resistance (Chemical) | Maintain "Excellent" or "Good" resistance to chemicals found in MDI canisters (Freon, Alcohol, Oleic Acid) and common cleaning agents (Sodium Sulfate, Sodium Carbonate, Trisodium Phosphate, Ethyl Alcohol, Methyl Alcohol, Propyl Alcohol, Oleic Acid). Resistance to other relevant chemicals at 72°F and 140°F. | Manufacturer's Data (Hoeschet Celanese Corp. - Attachment 1) and In-house Testing: - Alcohols (Ethyl, Methyl, Propyl), Freon, Sodium Sulfate, Trisodium Phosphate: Excellent resistance. - Oleic Acid, Sodium Carbonate: Good resistance. - Extensive table of "Chemical Resistance of 'Celcon' Acetal Copolymer Resin" at 72°F and 140°F (see full table in original document). |
| Durability (Cleaning) | No physical or cosmetic degradation after typical cleaning agents/conditions (e.g., alcohol, dishwashing liquid, vinegar, standard dishwasher cycles). | Cleaning Test: MedShield units were soaked for 5 days in alcohol, dishwashing liquid, and vinegar with no physical or cosmetic degradation noted. Units were subjected to 5 cycles of a standard dishwasher with no physical or cosmetic degradation noted. (Considered typical cleaning agents/conditions). |
| Durability (Impact) | Withstand repeated drops from a reasonable height without breakage. | Drop Test: MedShield units were dropped 10 times from a height of 1 meter onto a tile-covered cement floor without breakage. |
| Performance (Drug Deposition Reduction) | Reduce drug deposition on the tongue compared to no device or other devices. (Implied primary function, though not a quantifiable acceptance criterion with a specific threshold in the provided text). | Comparative Performance Testing: "In each instance tested, the medication deposited on the MedShield was less than that with other devices are cylindrical providing significantly more surface area to collect medication. The lower values for MedShield indicate that only medication that would be deposited on the tongue is affected." (Qualitative statement, no quantitative data or specific comparison devices mentioned). |
| Equivalence to Predicate Devices | Substantially equivalent to Micro Spacer and AeroChamber in terms of safety and effectiveness. | DHD believes the MedShield performs substantially equivalent to the predicate device(s) and does not adversely affect safety and effectiveness compared to the predicate device. (Conclusion based on the above tests and feature descriptions). |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the number of samples (MedShield units) used for each specific test (e.g., Cleaning Test, Drop Test, Comparative Performance Testing). It refers to "MedShield units" in plural for these tests. For the chemical resistance of the raw material (Celcon M90), the data provenance is "Hoeschet Celanese Corp." (the manufacturer of the resin). For the other tests (cleaning, drop, comparative performance), the data appears to be internally generated by DHD. The data is retrospective, as it's being presented as part of a 510(k) submission after the tests were conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission focuses on the material and physical properties of the device, not on clinical interpretation or diagnosis that would require expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The tests performed (chemical resistance, cleaning, drop, comparative performance) are objective physical/chemical tests, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The comparative performance testing was qualitative and focused on drug deposition on the device itself, not on human reader performance or clinical outcomes.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the material properties (chemical resistance) is based on manufacturer's specifications and test results for the raw material (Celcon M90 Acetal resin). For the in-house tests (cleaning, drop), the ground truth is the direct observation of physical and cosmetic degradation of the device under specific test conditions. For the "Comparative Performance Testing," the ground truth for "medication deposited" would likely be quantitative measurement of drug residue from the test setup, though specific methods are not detailed.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device; there is no AI algorithm or "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable (as above).
{0}------------------------------------------------
JUL 25 1996
510(k) SUMMARY As Required by 807.92(c)
DHD Diemolding Healthcare Division l. Submitter: 125 Rasbach Street Canastota, NY 13032
Phone: 315-697-2221 315-697-8083 Fax:
Contact:
Jean Wallace, Manager, Regulatory Affairs
Device Name 2.
| • Trade Name | - | MedShield |
|---|---|---|
| • Common name | - | Tongue Cover or Guard |
| • Classification name | - | Classification - Nebulizer, Direct patient Interface |
The Micro Spacer and the AeroChamber, designed for use with Metered-Dose Inhalers, are the 3. devices to which we are claiming equivalence.
Device Description 4.
The MedShield product reduces drug deposition in the tongue when used in conjunction with metered dose inhaler (MDI) medications. The device attaches to an MDI elbow and shields the tongue of the user from the medication spray. Drug that deposits on the device would otherwise be on the users tongue. Based on this, the taste effect of the medications is reduced.
This simple device includes two different features.
-
The patient end of the device covers the tongue. The patient end may vary to maximize the comfort of a wide range of users.
-
The elbow end of the device includes a universal clip, which attaches the device to all MDI elbows. To satisfy the preferences of various customers, the force required to separate (or attach) the device to various elbows can be modified by adjusting the clip or modifying the taper around the clip.
The MedShield product has been designed to conform with ASTM F963-92, "Standard Consumer Safety Specification on Toy Safety, under Section 4.6, Small Objects, specifically 4.6.2, Mouth-Actuated Toys, and CFR 16-1511.1, "Requirements For Pacifically, 1511.5 Structural integrity tests for Small Parts, 1511.5 (d), to ensure that the device does not present a choke hazard.
The MedShield is designed for single patient use. Patients may be given the product for use either in a hospital or home environment for extended time periods. Recommendations for cleaning, in cases of extended time, are included in the instructions for use.
{1}------------------------------------------------
As a prescription item, the labeling of the device contains the required caution statement: "Caution: Federal (USA) law restricts this device to sale by or on the order of a physician."
5. Intended Use
The DHD MedShield is a single-patient-use device. The Intended Use of the device is to reduce the taste effect of Metered Dose Inhaler (MDI) drugs by covering the tongue in the taste sensor area.
Technological Information 6.
MedShield, Microspacer and Aerochamber are used by attaching to a Metered Dose Inhaler (MDI) 6.1 elbow, placing part of the device in the mouth and administering the MDI. After activation of the MDI the user inhales the medication while keeping the device in the mouth.
MedShield attaches to the patient end of the MDI elbow via an integral clip. The patient end of the 6.2 MedShield masks the area of the tongue that it covers and medication that would have been deposited on that section of the tongue, is deposited on the MedShield.
Aerochamber attaches to the patient end of the MDI elbow via a flexible thermoplastic opening which 6.3 surrounds the outer diameter of the elbow patient end. A chamber is affixed to the opening which terminates in a valved mouthpiece at the patient end. After activation of the MDI, large particles impact and deposit within the walls and valving thereby reducing the amount released into the oral cavity of the patient.
Microspacer attaches to the patient end of the MDI elbow via a conical flexible opening. A small 6.4 (relative to Aerochamber) chamber is terminated by plastic grating at the patient end. After activation of the MDI, larger particles impact and deposit on the walls and grate reducing the amount released in the oral cavity of the patient.
6.5 Features and Specifications
MedShield is one piece and is positioned by on top of the patient's tongue. 6.5.1
Microspacer and Aerochamber have a patient end that serves as mouthpiece. The patient's lips 6.5.2 surround the mouthpiece and the patient then inhales through the device.
MedShield is opaque and approximately 1.5 inches by 2.5 inches, rectangular. 6.5.3
Microspacer is opaque and approximately a 1.75 inch long cylinder with a tapered diameter ranging 6.5.4 from 1.0 to 0.75 inches. The patient end of the cylinder contains an integral grate.
Aerochamber is opaque at each end and transparent in the center. The device consists of a 4.5 inch 6.5.5 long cylinder (1.75 inch inner diameter) with a 1.25 inch x 1.25 inch x 0.75 inch mouthpiece at the patient end and a flexible elliptical opening in which the MDI elbow is inserted.
A brief discussion of nonclinical tests conducted on this device and how the results support a 7. determination of substantial equivalent follows:
7.1 Environmental testing was completed to determine the effects of:
Chemical Resistance
The plastic selected for the MedShield is an Acetal resin - Celcon M90. This material has been tested by the manufacturer (Hoeschet Celanese Corp.-Attachment 1) for the effect of various chemicals on physical properties. The three sodium compounds listed are found in dishwasher powders. The Freon, Alcohol and Oleic Acid compounds are found in MDI canisters.
{2}------------------------------------------------
| CHEMICAL | RESISTANCE | CHEMICAL | RESISTANCE |
|---|---|---|---|
| Alcohols | Excellent | Freon | Excellent |
| Ethyl Alcohol | Excellent | Oleic Acid | Good |
| Methyl Alcohol | Excellent | Sodium Sulfate | Excellent |
| Propyl Alcohol | Excellent | Sodium Carbonate | Good |
| Trisodium Phosphate | Excellent |
Cleaning Test: MedShield units were soaked for 5 days in alcohol, dishwashing liquid and vinegar with no physical or cosmetic degradation noted. Units were subjected to 5 cycles of a standard dishwasher with no physical or cosmetic degradation noted. These are considered to be typical cleaning agents/conditions available to users.
Drop Test: MedShield units were dropped 10 times from a height of 1 meter onto a tile covered cement floor without breakage.
Comparative Performance Testing: In each instance tested, the medication deposited on the 7.2 MedShield was less than that with other devices are cylindrical providing significantly more surface area to collect medication. The lower values for MedShield indicate that only medication that would be deposited on the tongue is affected.
Based on the foregoing information, DHD believes the MedShield performs substantially equivalent to the predicate device(s) and in the opinion of DHD it is substantially equivalent to the predicate device(s) and does not adversely affect safety and effectiveness compared to the predicate device.
{3}------------------------------------------------
510(k) Premarket Notification - MedShield Environmental Testing
CHEMICAL RESISTANCE
The plastic selected for the MedShield is an Acetal resin - Celcon M90. This material has been tested by the manufacturer (Hoeschet Celanese Corp .- Attachment 1) for the effect of various chemicals on physical properties. The three sodium compounds listed are found in dishwasher powders. The Freon, Alcohol and Oleic Acid compounds are found in MDI canisters.
| CHEMICAL | RESISTANCE | CHEMICAL | RESISTANCE |
|---|---|---|---|
| Alcohols | Excellent | Freon | Excellent |
| Ethyl Alcohol | Excellent | Oleic Acid | Good |
| Methyl Alcohol | Excellent | Sodium Sulfate | Excellent |
| Propyl Alcohol | Excellent | Sodium Carbonate | Good |
| Trisodium Phosphate | Excellent |
CLEANING/DROP TESTING
Test Procedure per Sample Request # 432-96-2
CLEANING:
MedShield units were soaked for 5 days in alcohol, dishwashing liquid and vinegar with no physical or cosmetic degradation noted. Units were subjected to 5 cycles of a standard dishwasher with no physical or cosmetic degradation noted. These are considered to be typical cleaning agents/conditions available to users.
DROP:
MedShield units were dropped 10 times from a height of 1 meter onto a tile covered cement floor without breakage.
Attachment No. 1 Chemical Resistance of "Celcon" published by Hoeschet Celanese Corporation
63
{4}------------------------------------------------
TABLE I
CHEMICAL RESISTANCE OF "CELCON" ACETAL COPOLYMER RESIN
CODE: - - E-Excellent, G-Good, F-Fair, NG-No Good
| CHEMICAL | SUITABILITY FOR USEWITH "CELCON" | |
|---|---|---|
| 72°F | 140°F | |
| Acetaldehyde | E | G |
| Acetic Acid - 20% | F | NG |
| Acetic Acid - 80% | NG | NG |
| Acetic Anhydride | G | NG |
| Acetone | G | G |
| Adipic Acid | G | F |
| Alcohols | E | E |
| Alcohol-Amyl | E | E |
| Alcohol-Butyl | E | E |
| Aliphatic Hydrocarbons | E | E |
| Aluminum Chloride | F | NG |
| Aluminum Fluoride | F | F |
| Aluminum Hydroxide | G | F |
| Aluminum Oxychloride | NG | NG |
| Aluminum Nitrate | F | NG |
| Aluminum Sulfate | F | NG |
| Alums | G | F |
| Ammonia Gas-Dry | E | E |
| Ammonia Liquid | E | E |
| Ammonium Bifluoride | NG | NG |
| Ammonium Chloride | G | F |
| Ammonium Carbonate | E | E |
| Ammonium Fluoride 25% | G | F |
| Ammonium Hydroxide (all concentrations) | E | E |
| Ammonium Metaphosphate | E | E |
| CHEMICAL | 72°F | |
| Ammonium Thiocyanate | G | |
| Ammonium Nitrate | G | |
| Ammonium Phosphate | G | |
| Ammonium Sulfate | G | |
| Ammonium Persulfate | G | |
| Amyl Acetate | E | |
| Amyl Chloride | E | |
| Aniline | G | |
| Anthraquinone | E | |
| Anthraquinonesulfonic Acid | NG | |
| Antimony Trichloride | NG | |
| Aqua Regia (Dilute) | NG | |
| Aqua Regia (Concentrated) | NG | |
| Aromatic Hydrocarbons | E | |
| Arsenic Acid | NG | |
| Barium Carbonate | E | |
| Barium Chloride | E | |
| Barium Hydroxide | E | |
| Barium Sulfate | E | |
| Barium Sulfide | E | |
| Beer | E | |
| Beet Sugar Liquors | E | |
| Benzaldehyde | E | |
| Benzene or Benzol | E | |
| Benzoic Acid | G | |
| Bismuth Carbonate | E | |
| Bleach, Laundry 15% Active Cl2 | NG | |
| Borax | E | |
| Boric Acid | E | |
| Brine Solutions | E | |
| Bromine Liquid | NG | |
| Bromine Water | NG | |
| Butane | E | |
| Butadiene | E | |
| Butyl Acetate | E | |
| Butyl Alcohol | E |
Attachment No.1
64
{5}------------------------------------------------
0 L
. '
{6}------------------------------------------------
- 3 -
CHEMICAL
Calcium Bisulfite Calcium Carbonate Calcium Chlorate Calcium Chloride Calcium Hydroxide Calcium Hypochlorite Calcium Nitrate Calcium Sulfate Carbon Dioxide Carbon Dioxide - Dry Carbon Bisulfide Carbon Monoxide Carbon Tetrachloride Carbonic Acid Castor Oil Caustic Soda (all concentrations) Caustic Potash (all concentrations) Cellosolve Chloracetic Acid Chloral Hydrate Chloric Acid 20% Chlorine Gas (Dry) Chlorine Gas (Wet) Chlorine Water Chlorobenzene (Mono) Chloroform Chlorosulfonic Acid Chrome Alum Chromic Acid (all concentrations) Citric Acid Cocomit Oil Copper Chloride Copper Cyanide
72°F
F
E
E
II
ાં પે
പ്ര
દિવ
E
ದ್ರದ
E
E
E
്ച് പ്ര
E
ದ
E
E
G
NG
NG
NG
NG
द्ध
E
NG
C
NG
G
E
G
G
NG
NG
11
{7}------------------------------------------------
- 4 -
ਾ ਕੇ
| CHEMICAL | 72°F | |
|---|---|---|
| Copper Fluoride | G | |
| Copper Nitrate | E | |
| Copper Sulfate | E | |
| Cottonseed Oil | E | |
| Cresol | F | |
| Cresylic Acid - 50% | G | |
| Cyanide Plating Solutions | F | |
| Cyclohexanone | E | |
| Disodium Phosphate | G | |
| Distilled Water | E | |
| Dextrin | E | |
| Dextrose | E | |
| Diazo Salts | F | |
| Diglycolic Acid | G | |
| Dimethylamine | NG | |
| Dioctylphthalate | E | |
| Ethers | E | |
| Ethyl Acetate | E | |
| Ethyl Acrylate | G | |
| Ethyl Alcohol | E | |
| Ethyl Chloride | E | |
| Ethyl Ether | E | |
| Ethylene Bromide | E | |
| Ethylene Chlorhydrin | G | |
| Ethylene Dichloride | E | |
| Ethylene Glycol | E |
.
{8}------------------------------------------------
.
| CHEMICAL | 72°F | 140 |
|---|---|---|
| Fatty Acids | G | |
| Ferric Chloride | G | |
| Ferric Nitrate | G | |
| Ferric Sulfate | G | |
| Ferrous Chloride | G | |
| Ferrous Sulfate | G | |
| Fluoborate Salts | G | |
| Fluobroic Acid | NG | |
| Fluosilicic Acid and Salts | G | |
| Formaldehyde | E | |
| Formic Acid | NG | |
| Freon | E | |
| Fructose | E | |
| Fruit Juices, Pulp | E | |
| Gallic Acid | G | |
| Gasoline - Sour | E | |
| Gasoline - Refined | E | |
| Glycolic Acid | F | |
| Glucose | E | |
| Glycerine or Clycerol | E | |
| Glycols | E | |
| Heptane | E | |
| Hexane | E | |
| Hydrobromic Acid | NG | |
| Hydrochloric Acid (all concentrations) | NG | |
| Hydrocyanic Acid - Hydrogen Cyanide | E | |
| Hydrofluoric Acid | NG | |
| Hydrogen | E | |
| CHEMICAL | 72°F | |
| Hydrogen Peroxide (Dilute) | NG | |
| Hydrogen Peroxide (Concentrated) | NG | |
| Hydrogen Sulfide - Dry | G | |
| Hydrogen Sulfide - Wet Aqueous Sol. | F | |
| Hydroquinone | E | |
| Hydroxylamine Sulfate. | G | |
| Hypochlorous Acid | NG | |
| Iodine and Solutions | NG | |
| Kerosene | E | |
| Lacquer Solvents | E | |
| Lactic Acid | G | |
| Lard Oil | E | |
| Lauric Acid | G | |
| Lauryl Chloride | E | |
| Lead Acetate | E | |
| Linoleic Acid | G | |
| Linseed Oil | E | |
| Liqueurs | E |
{9}------------------------------------------------
- 6 -
ﺮ ﺍ
"
.
:
.
{10}------------------------------------------------
| -7- | |||
|---|---|---|---|
广
| CHEMICAL | 72°F |
|---|---|
| Magnesium Carbonate | E |
| Magnesium Chloride | E |
| Magnesium Hydroxide | E |
| Magnesium Nitrate | E |
| Magnesium Sulfate | E |
| Malic Acid | E |
| Maleic Acid | G |
| Mercuric Chloride | G |
| Mercuric Cyanide | E |
| Mercurous Nitrate | E |
| Mercury | E |
| Methyl Alcohol | E |
| Methyl Chloride | E |
| Methyl Ethyl Ketone | E |
| Methyl Sulfate | G |
| Methyl Sulfuric Acid | G |
| Methylene Chloride | NG |
| Milk | E |
| Mineral Oils | E |
| Mixed Acid - 40% Sulfuric, 15% Nitric | E |
| Molasses | NG |
| Mineral Spirits | E |
| Naptha | E |
| Natural Gas | E |
| Nickel Chloride | F |
| Nickel Nitrate | F |
| Nickel Sulfate | G |
| Nicotine | G |
| Nicotinic Acid | G |
| Nitric Acid - Dilute (under 25%) | NG |
| Nitric Acid - Conc. (42° Be.) | NG |
| Nitric Acid - Fuming | NG |
| Nitrobenzene | E |
:
{11}------------------------------------------------
| 81t |
|---|
| ------------- |
| CHEMICAL | 72°F | 140 |
|---|---|---|
| Oils & Fats | E | E |
| Oleic Acid | G | F |
| Oleum | NG | NG |
| Oxalic Acid | F | N |
| Oxygen | G | N |
| Ozone | NG | N |
| Palmitic Acid | G |
|---|---|
| Perchloroethylene | E |
| Petroleum - Crude | F |
| Phenol | G |
| Phenylhydrazine | G |
| Phosgene | NG |
| Phosphoric Acid - Dilute | NG |
| Phosphoric Acid - Medium Conc. | NG |
| Phosphoric Acid - Concentrated | NG |
| Phosphorous Trichloride | NG |
| Photographic Solutions | F |
| Phthalic Acid | G |
| Picric Acid | NG |
| Plating Solutions | F |
| Potassium Bicarbonate | G |
| Potassium Bichromate | NG |
| Potassium Borate | G |
| Potassium Bromate | F |
| Potassium Bromide | E |
| Potassium Carbonate | G |
| Potassium Chloride | E |
:
{12}------------------------------------------------
F
ﺎﻳﺎ
| CHEMICAL | 72°F |
|---|---|
| Potassium Dichromate | F |
| Potassium Ferricyanide | F |
| Potassium Ferrocyanide | F |
| Potassium Fluoride | E |
| Potassium Hydroxide (all concentrations) | E |
| Potassium Iodide | G |
| Potassium Nitrate | G |
| Potassium Perborate | F |
| Potassium Perchlorate | NG |
| Potassium Permanganate | NG |
| Potassium Persulfate | NG |
| Potassium Sulfate | E |
| Propane | E |
| Propyl Alcohol | E |
| Propylene Dichloride | E |
- 9 -
Rayon Coagulating Bath
.
ﻫﺪﻓﻪ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
| Sea Water | E |
|---|---|
| Selenic Acid | NG |
| Silicic Acid | E |
| Silver Cyanide | F |
| Silver Nitrate | F |
| Silver Plating Solutions | F |
| Soap Solutions | E |
| Sodium Acetate | E |
| Sodium Benzoate | G |
{13}------------------------------------------------
- 10 -
| CHEMICAL | |
|---|---|
| Sodium Bicarbonate | G |
| Sodium Bisulfate | G |
| Sodium. Bisulfite | G |
| Sodium Bromide | G |
| Sodium Carbonate | G |
| Sodium Chlorate | E |
| Sodium Chloride | G |
| Sodium Cyanide | F |
| Sodium Dichromate | G |
| Sodium Ferricyanide | G |
| Sodium Ferrocyanide | E |
| Sodium Fluoride | E |
| Sodium Hydroxide (all concentrations) | F |
| Sodium Hypochlorite | G |
| Sodium Nitrate | G |
| Sodium Nitrite | G |
| Sodium Silicate | E |
| Sodium Sulfate | E |
| Sodium Sulfide | E |
| Sodium Sulfite | G |
| Sodium Thiosulfate | E |
| Sour Crude Oil | G |
| Stannic Chloride | G |
| Stannous Chloride | G |
| Stearic Acid | G |
| Sugar Solutions | E |
| Sulfur Dioxide - Dry | E |
| Sulfur Dioxide - Wet | G |
| Sulfuric Acid - Dilute (Under 25%) | NG |
| Sulfuric Acid - Med. Conc. (25-80%) | NG |
| Sulfuric Acid - Conc. (over 80%) | NG |
| Sulfurous Acid | NG |
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{14}------------------------------------------------
| t | ]] | œ |
|---|---|---|
্রয়
| CHEMICAL | 72° F | 140° |
|---|---|---|
| Tannic Acid | G | |
| Tanning Liquors | G | |
| Tartaric Acids | G | |
| Tetraethyl Lead | વિ | |
| Thionyl Chloride | ||
| Tin Salts | ||
| Toluene or Toluol | ||
| Trichloroethylene | ||
| Triethanolamine | មា ប្រជាជាបានប្រជាជាតិ នៅក្រោយប្រជាជាតិ នៅ ប្រជាជនជ្រោះ ប្រជាជនជ្រោះ ប្រជាជនជ្រោះ ប្រជាជនជ្រោះ និង ប្រាសាទនេះ និង ប្រាសាទនេះ និង ប្រាសាទនេះ និង ប្រជាជនជ្រាប់ និង ប្រាសាទនេះ | |
| Triethylamine Trisodium Phosphate | ||
| Turpentine | ||
| UreaUrine | ામE | |
| Vinegar | E | |
| Water - Acid Mine WaterWater - Demineralized | ್ಕE | |
| Water - Fresh | ||
| Water - Salt | ದು ಧರ್ಮ ಧ್ರಿಗಳು ಧಾರ್ಮಿಸಿದ ಧರ್ಮಿಸಿದ ಧರ್ಮಿಸಿದ ಧರ್ಮಿಸಿದ ಧರ್ಮಿಸಿದ ಧರ್ಮಿಸಿದ ಧರ್ಮಿಸಿದ ಧರಿ ಧಾರ್ಮಿಸಿದ ಧರ್ಮಿಸಿದ ಧರ್ಮಿಸಿದ ಧರ್ಮಿಸಿದ ಧರ್ಮಿಸಿದ ಧರ್ಮಿಸಿದ ಧರ್ಮಿಸಿದ ಧರ್ಮಿಸಿ | |
| WhiskeyWhite Liquor | E |
:
M
{15}------------------------------------------------
- 12 -
| CHEMICAL | 72°F | 140°F |
|---|---|---|
| Xylene or Xylol | E | E |
| Zinc Chloride | F | F |
| Zinc Sulfate | F | F |
and the comments of the comments of the comments of
§ 868.5640 Medicinal nonventilatory nebulizer (atomizer).
(a)
Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.